**Anal Injectables and Implantables for Faecal Incontinence**

John Camilleri-Brennan

[75] Mergulhão MEA. Eletroestimulação, biofeedback e associação de eletroestimulação com biofeedback no tratamento da incontinência fecal [Dissertação]. Campinas: Fac‐

[76] Norton C, Whitehead W, Bliss DZ, Harari D Lang J. Conservative and Pharmacologi‐ cal Management of Faecal Incontinence in Adults. In: Abrams P, Cardozo L, Khoury S, Wein A, eds. Incontinence. Plymouth: Health Publications, 2009: 1323–86. [cited 2013 Sep. 04]. Avalilable from: http://www.ics.org/Publications/ICI\_4/book.pdf

[77] Norton C, Gibbs A, Kamm MA Randomized, Controlled Trial of Anal Electrical Stimulation for Fecal Incontinence. Diseases of the Colon & Rectum. 2006;49(2):190-6.

[78] Brito CMM, Schmidt FMQ, Canettieri MG, de La Quintana MM, Andrade PAS, Gi‐ menez TM. Reabilitação da Disfunção Vesicoesfincteriana. In: Brito CMM, Bazan M, Pinto C, Baia W, Battistella LR. Manual de Reabilitação em Oncologia do Instituto do

[79] Mahony RT, Malone PA, Nalty J, Behan M, O'Connell PR, O'Herlihy C. Randomized clinical trial of intra-anal electromyographic biofeedback physiotherapy with intraanal electromyographic biofeedback augmented with electrical stimulation of the anal sphincter in the early treatment of postpartum fecal incontinence. American

[80] Hosker G, Cody JD, Norton CC. Electrical stimulation for faecal incontinence in adults. Cochrane Database of Systematic Reviews 2007, Issue 3. Art. No.: CD001310.

[81] Costilla C, Foxx-orenstein E, Mayer P, Crowell M. office-based management of fecal

[82] Kenefick NJ. Sacral Nerve Neuromodulation for the Treatment of Lower Bowel Mo‐

[83] Mowatt G, Glazener CMA, Jarrett M. Sacral nerve stimulation for faecal incontinence and constipation in adults. Cochrane Database of Systematic Reviews 2007, Issue 3.

[84] Ratto C, Parello A, Donisi L, Doglietto GB. Sacral neuromodulation in the treatment

[85] Schreiner L. Eletroestimulação do nervo tibial no tratamento da incontinência uriná‐ ria de urgência em idosas [Dissertação]. Porto Alegre: Pontifícia Universidade Católi‐

[86] Souza GP, Suter TMC, Tonon E. Tratamento fisioterapêutico em incontinência fecal com estimulação elétrica do nervo tibial posterior e cinesioterapia: relato de caso. Re‐ vista Hórus. 2011;5(3). [cited 2013 Sep. 04]. Avalilable from: http://www.faeso.edu.br/

Câncer do Estado de São Paulo (ICESP). São Paulo: Manole; 2013. In press.

Journal of Obstetrics and Gynecology. 2004; 191:885-90.

incontinence. Gastroenterol Hepatol. 2013 jul;9(7):423-33.

tility Disorders. Ann R Coll Surg Engl. 2006;88(7): 617–623.

Art. No.: CD004464. DOI: 10.1002/14651858.CD004464.pub2

of defecation disorders. Acta Neurochir Suppl. 2007;97(Pt 1):341-50.

DOI: 0.1002/14651858.CD001310.pub2.

122 Fecal Incontinence - Causes, Management and Outcome

ca do Rio Grande do Sul; 2009.

horus/artigos%20anteriores/2011/CAP5.pdf

uldade de Ciências Médicas, Universidade Estadual de Campinas; 2004.

Additional information is available at the end of the chapter

http://dx.doi.org/10.5772/58327

#### **1. Introduction**

Faecal Incontinence (FI) can have an adverse effect on quality of life. It is a stigmatising condition that may lead to severe social restriction. From the financial point of view, the investigation and treatment of faecal incontinence may add to a significant cost to the health systems of most countries. In fact, the annual treatment cost of patients in the U.K. with urinary and faecal incontinence is of about £500 million.

Many factors may be involved in the pathophysiology of FI. A thorough clinical assessment of the patient is therefore mandatory. This starts with a full history, which may include a cognitive assessment if necessary. The characteristics of the faeces and the type and frequency of incontinence should be noted. Urge incontinence is suggestive of poor external anal sphincter function, whilst passive and post-defaecatory incontinence indicate that internal anal sphincter function is weak. Various questionnaires that enable the clinician to quantify the degree of incontinence and the impact on quality of life are available. These include symptomspecific questionnaires, such as the ones developed by Vaizey et al [1] and Wexner et al [2], the Faecal Incontinence Quality of Life Scale (FIQOL) developed by Rockwood et al [3], and also generic questionnaires such as the Short Form 36 (SF 36) [4].

A full examination of the patient, including the abdomen and perineum, and a neurological examination in some cases, is necessary. Beneficial investigations include a flexible sigmoido‐ scopy, anal manometry (resting and squeeze pressure), rectal compliance, pudendal nerve terminal motor latency (PNTML) and endoanal ultrasound.

The management of FI is usually multidisciplinary, involving the general practitioner, continence nurse, physiotherapist, gastroenterologist, urologist and colorectal surgeon.

Conservative measures, which include patient education and support, improvement in diet and bowel habit, judicious use of anti-diarrhoeal medication and pelvic floor exercises, are used in the first instance. This is, in fact, recommended in the UK by the National Institute for Clinical Excellence (NICE) guideline 'CG49 Faecal Incontinence' [5]. If these measures fail, however, surgical intervention may be necessary. A variety of surgical options are available, with the appropriate therapy being selected depending on the cause of the incontinence and the patient's cognitive function and general physical condition (Table 1). One of the surgical options available is the use of anal bulking agents.

**2. Anal bulking agents**

pressure within the anal sphincter.

The evidence for anal bulking agents

**2.1. Initial studies: The first phase**

repeated injections [10].

Gatekeeper.

Anal bulking agents have emerged as a treatment for F.I. following the success of bulking agents for urinary stress incontinence in females. In the urology setting, bulking agents have been employed to augment the bladder neck and increase urethral resistance [6]. Therefore, the aim of anal bulking agents is to prevent F.I. by closing the anal canal or increasing the

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The ideal characteristics of a bulking agent have been described in the literature [7]. The injected or implanted substance should be biocompatible, non-migratory, non-allergenic and non-carcinogenic. The substance should also be easy to inject or implant and should produce

Anal injectables and implantables have been used to manage faecal incontinence for over 20 years. It may be useful to chart their development over the years and to classify this develop‐ ment into three phases. The first phase consists of the initial experimental studies that took place in the nineties. The second phase, from about the year 2000 onwards, encompasses an increase in the number of studies using a wide variety of agents and injection techniques. The third phase features the latest generation of anal bulking agents, the implantable THD

Anal bulking agents were first described in 1993 by Shafik [8]. Shafik, an Egyptian surgeon, is considered to be a pioneer in this field. In his first study, he described the outcomes following the injection of 5ml of PTFE (Polytef / Teflon) paste in 11 patients, 7 of whom had incontinence following a lateral internal sphincterotomy for anal fissure. In another study, the same author used 60 ml of abdominal wall fat as a submucosal injection into the rectal neck at 3 and 9 o'clock in 14 patients with partial faecal incontinence [9]. Pescatori's group from Rome, Italy, reported the use of anal injection of autologous buttock fat to restore continence in one patient who had poor results following a sphincteroplasty. This patient's continence improved following

The indications for injection of the anal bulking agents in these studies were various. Most patients had passive FI, but some had urge incontinence, indicating EAS disruption. The results of these initial studies showed that continence was improved in the short term. However, the medium and long-term results were poor, probably because of resorbtion or migration of the

A number of safety issues were raised with these studies. Teflon could potentially cause granuloma formation and sarcomas. The injection of autologous fat as a bulking agent in

injected material. Re-injection was necessary in order to maintain continence.

urology has been implicated in fatal fat embolism and stroke.

an improvement in continence, both in the short-term as well as in the long-term.


**Table 1.** Surgical Options in the Management of Faecal Incontinence

#### **2. Anal bulking agents**

Conservative measures, which include patient education and support, improvement in diet and bowel habit, judicious use of anti-diarrhoeal medication and pelvic floor exercises, are used in the first instance. This is, in fact, recommended in the UK by the National Institute for Clinical Excellence (NICE) guideline 'CG49 Faecal Incontinence' [5]. If these measures fail, however, surgical intervention may be necessary. A variety of surgical options are available, with the appropriate therapy being selected depending on the cause of the incontinence and the patient's cognitive function and general physical condition (Table 1). One of the surgical

options available is the use of anal bulking agents.

124 Fecal Incontinence - Causes, Management and Outcome

**1. Restoration and improvement of residual sphincter function** a. Correcting a defective External Anal Sphincter: Sphincteroplasty (End-to-end repair; Overlap repair)

b. Correcting a defective Pelvic Floor:

c. Correction of Anorectal Deformities

e. Posterior Tibial Nerve Stimulation (PTNS) **2. Increasing the outlet resistance of the anal sphincter**

a. Augmentation of the Anal Sphincter and Anal Cushions (Anal Bulking Agents)

d. Sacral Nerve Stimulation (SNS)

b. Anal Submucosal Fibrosis (SECCA)

d. Non-Dynamic Graciloplasty

**3. Dynamic Sphincter Replacement** a. Dynamic Graciloplasty b. Artificial Anal Sphincter **4. Antegrade Continence Enema (ACE)**

**5. Faecal Diversion**

a. Colostomy b. Ileostomy

c. Anal Encirclement (Thiersch procedure)

**Table 1.** Surgical Options in the Management of Faecal Incontinence

Levatorplasty Postanal Repair

Total Pelvic Floor Repair

Anal bulking agents have emerged as a treatment for F.I. following the success of bulking agents for urinary stress incontinence in females. In the urology setting, bulking agents have been employed to augment the bladder neck and increase urethral resistance [6]. Therefore, the aim of anal bulking agents is to prevent F.I. by closing the anal canal or increasing the pressure within the anal sphincter.

The ideal characteristics of a bulking agent have been described in the literature [7]. The injected or implanted substance should be biocompatible, non-migratory, non-allergenic and non-carcinogenic. The substance should also be easy to inject or implant and should produce an improvement in continence, both in the short-term as well as in the long-term.

The evidence for anal bulking agents

Anal injectables and implantables have been used to manage faecal incontinence for over 20 years. It may be useful to chart their development over the years and to classify this develop‐ ment into three phases. The first phase consists of the initial experimental studies that took place in the nineties. The second phase, from about the year 2000 onwards, encompasses an increase in the number of studies using a wide variety of agents and injection techniques. The third phase features the latest generation of anal bulking agents, the implantable THD Gatekeeper.

#### **2.1. Initial studies: The first phase**

Anal bulking agents were first described in 1993 by Shafik [8]. Shafik, an Egyptian surgeon, is considered to be a pioneer in this field. In his first study, he described the outcomes following the injection of 5ml of PTFE (Polytef / Teflon) paste in 11 patients, 7 of whom had incontinence following a lateral internal sphincterotomy for anal fissure. In another study, the same author used 60 ml of abdominal wall fat as a submucosal injection into the rectal neck at 3 and 9 o'clock in 14 patients with partial faecal incontinence [9]. Pescatori's group from Rome, Italy, reported the use of anal injection of autologous buttock fat to restore continence in one patient who had poor results following a sphincteroplasty. This patient's continence improved following repeated injections [10].

The indications for injection of the anal bulking agents in these studies were various. Most patients had passive FI, but some had urge incontinence, indicating EAS disruption. The results of these initial studies showed that continence was improved in the short term. However, the medium and long-term results were poor, probably because of resorbtion or migration of the injected material. Re-injection was necessary in order to maintain continence.

A number of safety issues were raised with these studies. Teflon could potentially cause granuloma formation and sarcomas. The injection of autologous fat as a bulking agent in urology has been implicated in fatal fat embolism and stroke.

#### **2.2. The second phase**

The second phase in the development of anal bulking agents consisted of a wide variation in the types of materials used, surgical technique and clinical indications [11]. Some of the materials used to bulk the anal sphincter were being used in urology to augment the bladder neck. Nine different types of injectable bulking agents have been used in these studies (Table 2).

Indications:

These were:

such as scleroderma

Indications:

amenable to surgical repair.

**•** Defect in the external anal sphincter (EAS)

Surgical Procedure and Technique:

Metronidazole 500mg at induction.

an 18G needle [14].

Metronidazole 500mg at induction.

Surgical Procedure and Technique:

The clinical indications for which these bulking agents were used varied from study to study.

**•** Structurally intact but weak internal anal sphincter (IAS). This would be due to either primary idiopathic degeneration of the IAS, or degeneration secondary to tissue disorders

> the IAS, or degeneration secondary to tissue disorders such as scleroderma • IAS damage (childbirth, haemorrhoidectomy, anal stretch, sphincterotomy) (Figure 1)

The clinical indications for which these bulking agents were used varied from study to study. These were:

The main indication was IAS dysfunction or disruption. Unlike the EAS, the IAS is not amenable to surgical repair.

Figure 1: Endoanal ultrasound scan showing a defect in the IAS of a 57year old lady with passive faecal incontinence following

The bulking agents may be inserted under local, regional (anal or pudendal nerve block) or general anaesthesia. The type of anaesthesia used depends on the preference of the patient and the surgeon. The patient may be positioned in the prone (jack-knife), lithothomy or left lateral positions, although the latter position may not give a satisfactory view of the anorectum to enable accurate injection. A phosphate enema is usually administered preoperatively. The procedure is usually covered by prophylactic antibiotics, such as intravenous (IV) Co-amoxiclav 1.2g, Cefuroxime 750mg and Metronidazole 500mg or Gentamicin 1.5mg/kg and

The injection of the bulking agent varies depending on the type of substance used and the clinical indications. Three different routes of needle insertion were mentioned in the literature: transmucosal, trans-sphincteric or intersphincteric. The bulking agent was placed submucosally, within the intersphincteric space or within the IAS itself. For example, porcine dermal collagen (Permacol) may be injected via the transmucosal or trans-sphincteric route using a disposable 19G needle [12] (Figure 2). In patients with an intact IAS, 2.5ml of Permacol is equally injected into the submucosal space at the 3, 7 and 11 o'clock positions above the dentate line. In cases of an IAS defect, 5ml of Permacol may be injected at the site of the defect, with 2.5ml of the substance injected diametrically opposite. With silicone biomaterial (PTQ or Bioplastique), four doses of 2.5ml of silicone are used, using an 18G needle [13, 14]. Patients with an intact IAS have the silicone injected trans-sphincterically into the intersphincteric space at the 2, 4, 8 and 10 o'clock positions. In patients with an IAS defect, for example after a lateral internal sphincterotomy, a total of three doses of 2.5 ml of silicone are injected into the defect. A fourth dose is injected into the intersphincteric space contralateral to the IAS defect, to provide symmetry. With carbon-coated beads (Durasphere) a total of 10ml are injected in four divided doses in the submucosal plane using

• Structurally intact but weak internal anal sphincter (IAS). This would be due to either primary idiopathic degeneration of

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The main indication was IAS dysfunction or disruption. Unlike the EAS, the IAS is not

**Figure 1.** Endoanal ultrasound scan showing a defect in the IAS of a 57year old lady with passive faecal incontinence following haemorrhoidectomy. The defect is present between the arrows from the 3 to the 5 o'clock positions.

The bulking agents may be inserted under local, regional (anal or pudendal nerve block) or general anaesthesia. The type of anaesthesia used depends on the preference of the patient and the surgeon. The patient may be positioned in the prone (jack-knife), lithothomy or left lateral positions, although the latter position may not give a satisfactory view of the anorectum to enable accurate injection. A phosphate enema is usually administered preoperatively. The procedure is usually covered by prophylactic antibiotics, such as intravenous (IV) Coamoxiclav 1.2g, Cefuroxime 750mg and Metronidazole 500mg or Gentamicin 1.5mg/kg and

haemorrhoidectomy. The defect is present between the arrows from the 3 to the 5 o'clock positions.

**•** IAS damage (childbirth, haemorrhoidectomy, anal stretch, sphincterotomy) (Figure 1)

• Failure of conservative management of faecal incontinence

**•** Failure of conservative management of faecal incontinence

• Defect in the external anal sphincter (EAS)


**Table 2.** Injectable materials used in the second phase of studies

Indications:

**2.2. The second phase**

**Type of Bulking agent Commercial**

126 Fecal Incontinence - Causes, Management and Outcome

Silicone biomaterial. Polydimethylsiloxane elastomer particles suspended in a biocompatible hydrogel made of poly-N-

Carbon-coated zirconium beads, comprised of pyrolytic carbon-coated beads suspended in a water-based carrier

gel containing β-glucan

Spherical particles of calcium

hydroxylapatite, suspended in a gel carrier

Dextranomer microspheres and stabilized sodium hyaluronate in phosphatebuffered 0.9% sodium chloride solution

Synthetic non-particulate hydrogel consisting of water (97.5%) and crosslinked polyacrylamide (2·5%)

Cross-linked porcine dermal collagen

8% Ethylene Vinyl alcohol co-polymer dissolved in dimethyl sulphoxide. A spongy solid mass forms from the solidification of the hydrophobic co-polymer when the solvent diffuses away on contact with

Expandable silicone Microballoons filled with a biocompatible hydrogel made of

**Table 2.** Injectable materials used in the second phase of studies

poly-N-vinyl-pyrrolidone

matrix

tissue fluid

**name/s**

NASHA Dx, Zuidex,

Glutaraldehyde cross-linked collagen Contigen Submucosal Transmucosal 2 90

Permacol Submucosal;

Solesta

2).

vinyl-pyrrolidone

The second phase in the development of anal bulking agents consisted of a wide variation in the types of materials used, surgical technique and clinical indications [11]. Some of the materials used to bulk the anal sphincter were being used in urology to augment the bladder neck. Nine different types of injectable bulking agents have been used in these studies (Table

PTQ; Bioplastique Intersphincteric

; within IAS

Durasphere Submucosal Transmucosal;

**Injection site Injection route Publishe**

Transsphincteric

Submucosal Transmucosal 4 56

Transmucosal; Intersphincteric

Submucosal Transmucosal 1 6

Coaptite Submucosal Transsphincteric 1 10

Bulkamid Intersphincteric Intersphincteric 1 5

Onyx34 Intershincteric Intersphincteric 1 21

Intersphincteric

**d studies**

7 187

5 172

Transsphincteric 21 619

**No. of patients** The clinical indications for which these bulking agents were used varied from study to study. These were:


The main indication was IAS dysfunction or disruption. Unlike the EAS, the IAS is not amenable to surgical repair. Figure 1: Endoanal ultrasound scan showing a defect in the IAS of a 57year old lady with passive faecal incontinence following

haemorrhoidectomy. The defect is present between the arrows from the 3 to the 5 o'clock positions.

Surgical Procedure and Technique: The bulking agents may be inserted under local, regional (anal or pudendal nerve block) or general anaesthesia. The type of **Figure 1.** Endoanal ultrasound scan showing a defect in the IAS of a 57year old lady with passive faecal incontinence following haemorrhoidectomy. The defect is present between the arrows from the 3 to the 5 o'clock positions.

anaesthesia used depends on the preference of the patient and the surgeon. The patient may be positioned in the prone (jack-knife),

symmetry. With carbon-coated beads (Durasphere) a total of 10ml are injected in four divided doses in the submucosal plane using

#### lithothomy or left lateral positions, although the latter position may not give a satisfactory view of the anorectum to enable accurate injection. A phosphate enema is usually administered preoperatively. The procedure is usually covered by prophylactic antibiotics, Surgical Procedure and Technique:

an 18G needle [14].

such as intravenous (IV) Co-amoxiclav 1.2g, Cefuroxime 750mg and Metronidazole 500mg or Gentamicin 1.5mg/kg and Metronidazole 500mg at induction. The injection of the bulking agent varies depending on the type of substance used and the clinical indications. Three different routes of needle insertion were mentioned in the literature: transmucosal, trans-sphincteric or intersphincteric. The bulking agent was placed submucosally, within the intersphincteric space or within the IAS itself. For example, porcine dermal collagen (Permacol) may be injected via the transmucosal or trans-sphincteric route using a disposable 19G needle [12] (Figure 2). In patients with an intact IAS, 2.5ml of Permacol is equally injected into the submucosal space at the 3, 7 and 11 o'clock positions above the dentate line. In cases of an IAS defect, 5ml of Permacol may be injected at the site of the defect, with 2.5ml of the substance injected diametrically opposite. With silicone biomaterial (PTQ or Bioplastique), four doses of 2.5ml of silicone are used, using an 18G needle [13, 14]. Patients with an intact IAS have the silicone injected trans-sphincterically into the intersphincteric space at the 2, 4, 8 and 10 o'clock positions. In patients with an IAS defect, for example after a lateral internal sphincterotomy, a total of three doses of 2.5 ml of silicone are injected into the defect. A fourth dose is injected into the intersphincteric space contralateral to the IAS defect, to provide The bulking agents may be inserted under local, regional (anal or pudendal nerve block) or general anaesthesia. The type of anaesthesia used depends on the preference of the patient and the surgeon. The patient may be positioned in the prone (jack-knife), lithothomy or left lateral positions, although the latter position may not give a satisfactory view of the anorectum to enable accurate injection. A phosphate enema is usually administered preoperatively. The procedure is usually covered by prophylactic antibiotics, such as intravenous (IV) Coamoxiclav 1.2g, Cefuroxime 750mg and Metronidazole 500mg or Gentamicin 1.5mg/kg and Metronidazole 500mg at induction.

The injection of the bulking agent varies depending on the type of substance used and the clinical indications. Three different routes of needle insertion were mentioned in the literature: transmucosal, trans-sphincteric or intersphincteric. The bulking agent was placed submuco‐ sally, within the intersphincteric space or within the IAS itself. For example, porcine dermal collagen (Permacol) may be injected via the transmucosal or trans-sphincteric route using a disposable 19G needle [12] (Figure 2). In patients with an intact IAS, 2.5ml of Permacol is equally injected into the submucosal space at the 3, 7 and 11 o'clock positions above the dentate line. In cases of an IAS defect, 5ml of Permacol may be injected at the site of the defect, with 2.5ml of the substance injected diametrically opposite. With silicone biomaterial (PTQ or Bioplastique), four doses of 2.5ml of silicone are used, using an 18G needle [13, 14]. Patients with an intact IAS have the silicone injected trans-sphincterically into the intersphincteric space at the 2, 4, 8 and 10 o'clock positions. In patients with an IAS defect, for example after a lateral internal sphincterotomy, a total of three doses of 2.5 ml of silicone are injected into the defect. A fourth dose is injected into the intersphincteric space contralateral to the IAS defect, to provide symmetry. With carbon-coated beads (Durasphere) a total of 10ml are injected in four divided doses in the submucosal plane using an 18G needle [14].

Results:

physical and social function.

was safer, than Durasphere.

control group had an improvement in their continence.

silicone biomaterial (PTQ) compared with digital guidance [13].

of life improvements that mattered to the patients.

recommended before using this agent [14].

The majority of studies in this second phase of development were mainly case series and observational studies. Most of these studies reported either an improvement in the faecal continence scores or less frequent episodes of incontinence over time. Anorectal manometry testing featured in some studies, with some showing an improvement in resting or squeeze pressures. Others studies showed no such improvement. Clinical improvement was not always associated with an increase in these pressures. Quality of life was formally assessed in some of these studies. The majority reported an improvement across various domains such as

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To date there have been five randomised trials using anal bulking agents, with a total of 382 patients. Two trials compared a bulking agent with a sham or saline injection. Siproudhis et al in 2007 [15] compared a silicone biomaterial (PTQ) with a normal saline injection (control) into the intersphincteric space. PTQ did not demonstrate any appreciable clinical benefit when compared to the control. The trial was however deemed to be too small to detect any differences in continence. Graf et al in 2011[16] compared the injection of dextranomer (NASHADx) against sham injection (no substance injected). Continence was better in the short term (6 months) in the active intervention group, although interestingly about 30% of patients in the

A small study with ten patients by Maeda et al in 2008 [17] revealed significant improvement at 6 weeks post injection using injection of Bulkamid and Permacol. Continence decreased slightly in the Permacol group at 6 months. However there was no reported difference between the two agents. The numbers were too small to detect a difference. Tjandra et al in 2009, reported the results of a randomised study comparing PTQ with carbon-coated beads (Dura‐ sphere) [14]. PTQ injection was associated with better continence scores and quality of life, and

Tjandra et al in 2004 reported the short-term benefits from ultrasound guided injection of

The follow up for the majority of patients in studies was less than a median of 3 years. A question on the term durability and effectiveness of these agents is therefore raised. The majority (97%) of patients were only followed up once or twice. No long-term evidence on outcomes was available and further conclusions were not warranted from the available data. None of the studies reported patient evaluation of outcomes and thus it is difficult to gauge whether the improvement in the continence scores matched the practical symptom and quality

The majority of patients did not report any complications. The complications described were mainly pain, anal bruising and leakage of injected material [11, 12]. Less common complica‐ tions were anal ulceration and infection (local cellulitis and abscess formation). There were two reported cases of local giant cell foreign body reaction after injection of silicone (PTQ)[18]. Durasphere has been associated with skin rashes and arthritis. Skin patch testing is therefore

It is of utmost importance to ensure that the anal mucosa is not breached during injection, since that would allow intra-anal leakage of the substance. Intravascular injection must also be avoided.

Once the injection is completed, it is good practice to leave the needle and syringe in place for a few seconds. As the needle is being withdrawn, pressure on the needle track by the index finger may prevent leakage of the bulking agent [12].

The bulking agent may be injected freehand, with an anal retractor such as Eisenhammer used to identify the IAS and intersphincteric groove. A finger placed within the anal canal may be useful to guide the needle to its correct position. However endoanal ultrasound has been recommended to guide the needle to an optimum position [13], especially if the agent is to be injected into the intersphincteric space or adjacent to a defect in the IAS.

**Figure 2.** Porcine dermal collagen (Permacol) in a 2.5ml syringe

#### Results:

The injection of the bulking agent varies depending on the type of substance used and the clinical indications. Three different routes of needle insertion were mentioned in the literature: transmucosal, trans-sphincteric or intersphincteric. The bulking agent was placed submuco‐ sally, within the intersphincteric space or within the IAS itself. For example, porcine dermal collagen (Permacol) may be injected via the transmucosal or trans-sphincteric route using a disposable 19G needle [12] (Figure 2). In patients with an intact IAS, 2.5ml of Permacol is equally injected into the submucosal space at the 3, 7 and 11 o'clock positions above the dentate line. In cases of an IAS defect, 5ml of Permacol may be injected at the site of the defect, with 2.5ml of the substance injected diametrically opposite. With silicone biomaterial (PTQ or Bioplastique), four doses of 2.5ml of silicone are used, using an 18G needle [13, 14]. Patients with an intact IAS have the silicone injected trans-sphincterically into the intersphincteric space at the 2, 4, 8 and 10 o'clock positions. In patients with an IAS defect, for example after a lateral internal sphincterotomy, a total of three doses of 2.5 ml of silicone are injected into the defect. A fourth dose is injected into the intersphincteric space contralateral to the IAS defect, to provide symmetry. With carbon-coated beads (Durasphere) a total of 10ml are injected in four

It is of utmost importance to ensure that the anal mucosa is not breached during injection, since that would allow intra-anal leakage of the substance. Intravascular injection must also be

Once the injection is completed, it is good practice to leave the needle and syringe in place for a few seconds. As the needle is being withdrawn, pressure on the needle track by the index

The bulking agent may be injected freehand, with an anal retractor such as Eisenhammer used to identify the IAS and intersphincteric groove. A finger placed within the anal canal may be useful to guide the needle to its correct position. However endoanal ultrasound has been recommended to guide the needle to an optimum position [13], especially if the agent is to be

divided doses in the submucosal plane using an 18G needle [14].

injected into the intersphincteric space or adjacent to a defect in the IAS.

finger may prevent leakage of the bulking agent [12].

128 Fecal Incontinence - Causes, Management and Outcome

**Figure 2.** Porcine dermal collagen (Permacol) in a 2.5ml syringe

avoided.

The majority of studies in this second phase of development were mainly case series and observational studies. Most of these studies reported either an improvement in the faecal continence scores or less frequent episodes of incontinence over time. Anorectal manometry testing featured in some studies, with some showing an improvement in resting or squeeze pressures. Others studies showed no such improvement. Clinical improvement was not always associated with an increase in these pressures. Quality of life was formally assessed in some of these studies. The majority reported an improvement across various domains such as physical and social function.

To date there have been five randomised trials using anal bulking agents, with a total of 382 patients. Two trials compared a bulking agent with a sham or saline injection. Siproudhis et al in 2007 [15] compared a silicone biomaterial (PTQ) with a normal saline injection (control) into the intersphincteric space. PTQ did not demonstrate any appreciable clinical benefit when compared to the control. The trial was however deemed to be too small to detect any differences in continence. Graf et al in 2011[16] compared the injection of dextranomer (NASHADx) against sham injection (no substance injected). Continence was better in the short term (6 months) in the active intervention group, although interestingly about 30% of patients in the control group had an improvement in their continence.

A small study with ten patients by Maeda et al in 2008 [17] revealed significant improvement at 6 weeks post injection using injection of Bulkamid and Permacol. Continence decreased slightly in the Permacol group at 6 months. However there was no reported difference between the two agents. The numbers were too small to detect a difference. Tjandra et al in 2009, reported the results of a randomised study comparing PTQ with carbon-coated beads (Dura‐ sphere) [14]. PTQ injection was associated with better continence scores and quality of life, and was safer, than Durasphere.

Tjandra et al in 2004 reported the short-term benefits from ultrasound guided injection of silicone biomaterial (PTQ) compared with digital guidance [13].

The follow up for the majority of patients in studies was less than a median of 3 years. A question on the term durability and effectiveness of these agents is therefore raised. The majority (97%) of patients were only followed up once or twice. No long-term evidence on outcomes was available and further conclusions were not warranted from the available data. None of the studies reported patient evaluation of outcomes and thus it is difficult to gauge whether the improvement in the continence scores matched the practical symptom and quality of life improvements that mattered to the patients.

The majority of patients did not report any complications. The complications described were mainly pain, anal bruising and leakage of injected material [11, 12]. Less common complica‐ tions were anal ulceration and infection (local cellulitis and abscess formation). There were two reported cases of local giant cell foreign body reaction after injection of silicone (PTQ)[18]. Durasphere has been associated with skin rashes and arthritis. Skin patch testing is therefore recommended before using this agent [14].

#### **2.3. The third phase: The implantable THD Gatekeeper**

A relatively new and innovative development in anal bulking technology is the THD Gate‐ keeper (THD S.p.A., Correggio, Italy). The material used is Polyacrylonitrile or Hyexpan. It is an inert, non-allergenic, non-degradable material that is also non-immunogenic, and noncarcinogenic. First developed by Medtronic in Minneapolis, USA, it was originally used as an implant in the oesophagogastric junction for the management of gastro-oesophageal reflux disease.

DISPENSER

causing trauma to the anal sphincter (Figure 5).

DELIVERY SYSTEM

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**Figure 3.** The Gatekeeper gun, made of the dispenser that houses one prosthesis, and the delivery system.

**Figure 4.** a. Shape of Hyexpan cylinders at insertion. b. Fully expanded Hyexpan cylinder following contact with water

The operation is performed under regional or general anesthesia. Intravenous antibiotics are given at induction. The author's patients receive Gentamicin 1.5 mg/kg and Metronidazole 500mg IV. The patient is placed in the lithotomy position. A strict sterile technique is used. The IAS and intersphincteric groove are identified by the placement of an anal retractor (eg. Eisenhammer or Park's). The author's preference is a THD surgy Mini-light proctoscope, a self illuminating anal and rectal retractor that gives a very good view of the anorectum without

The main indications for the use of the THD Gatekeeper are passive faecal incontinence, secondary to IAS dysfunction or damage, where conservative measures or injection of other bulking agents such as PTQ or Permacol have failed.

The following are contraindications to the use of the Gatekeeper. Similar contraindications have also been described by the product manufacturers of other anal bulking agents.


Surgical Apparatus, Procedure and Technique:

Whereas the anal bulking agents that were developed in phases 1 and 2 are injected into or around the anal canal by means of a hypodermic syringe, the Hyexpan prostheses are implanted into the intersphincteric space using a custom-made gun (Figure 3).

The prostheses consist of thin solid cylinders, 22mm long and 2mm in diameter. The success of this material depends on its hydrophilic properties. Within 24 hours after implantation in human tissue, the Hyexpan cylinders absorb water to become thicker and shorter. The *in vitro* maximum diameter is 6.5 mm and the length is 17 mm (Figure 4). The volume of each individual implant increases from approximately 70mm3 to 500mm3 , a 750% increase. The implant is also much softer in consistency compared to the firm consistency prior to implan‐ tation.

**2.3. The third phase: The implantable THD Gatekeeper**

130 Fecal Incontinence - Causes, Management and Outcome

bulking agents such as PTQ or Permacol have failed.

**•** Rectal or colon cancer undergoing active treatment;

**•** Rectal bleeding of unknown or undiagnosed origin;

**•** Pregnancy or planned pregnancy in the next 12 months.

individual implant increases from approximately 70mm3

**•** Uncontrolled blood coagulation disorders

Surgical Apparatus, Procedure and Technique:

disease.

**•** Perianal sepsis

colitis)

**•** Anal cancer

**•** Rectal prolapse

**•** Pelvic radiotherapy

**•** Immunosuppression

tation.

A relatively new and innovative development in anal bulking technology is the THD Gate‐ keeper (THD S.p.A., Correggio, Italy). The material used is Polyacrylonitrile or Hyexpan. It is an inert, non-allergenic, non-degradable material that is also non-immunogenic, and noncarcinogenic. First developed by Medtronic in Minneapolis, USA, it was originally used as an implant in the oesophagogastric junction for the management of gastro-oesophageal reflux

The main indications for the use of the THD Gatekeeper are passive faecal incontinence, secondary to IAS dysfunction or damage, where conservative measures or injection of other

The following are contraindications to the use of the Gatekeeper. Similar contraindications

**•** Inflammatory bowel diseases with anorectal involvement (Crohn's disease, ulcerative

Whereas the anal bulking agents that were developed in phases 1 and 2 are injected into or around the anal canal by means of a hypodermic syringe, the Hyexpan prostheses are

The prostheses consist of thin solid cylinders, 22mm long and 2mm in diameter. The success of this material depends on its hydrophilic properties. Within 24 hours after implantation in human tissue, the Hyexpan cylinders absorb water to become thicker and shorter. The *in vitro* maximum diameter is 6.5 mm and the length is 17 mm (Figure 4). The volume of each

implant is also much softer in consistency compared to the firm consistency prior to implan‐

to 500mm3

, a 750% increase. The

implanted into the intersphincteric space using a custom-made gun (Figure 3).

have also been described by the product manufacturers of other anal bulking agents.

**Figure 3.** The Gatekeeper gun, made of the dispenser that houses one prosthesis, and the delivery system.

**Figure 4.** a. Shape of Hyexpan cylinders at insertion. b. Fully expanded Hyexpan cylinder following contact with water

The operation is performed under regional or general anesthesia. Intravenous antibiotics are given at induction. The author's patients receive Gentamicin 1.5 mg/kg and Metronidazole 500mg IV. The patient is placed in the lithotomy position. A strict sterile technique is used. The IAS and intersphincteric groove are identified by the placement of an anal retractor (eg. Eisenhammer or Park's). The author's preference is a THD surgy Mini-light proctoscope, a self illuminating anal and rectal retractor that gives a very good view of the anorectum without causing trauma to the anal sphincter (Figure 5).

The steps may be repeated to insert between four to six prostheses, equidistant from each other. The choice of inserting 4 as opposed to 6 prostheses is arbitrary. The wounds are closed with a single absorbable suture (Figure 8). At the end of procedure, EAUS imaging will show the

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**Figure 7.** THD Gatekeeper needle at the 9 o'clock position, with the endoanal ultrasound probe in place to determine

**Figure 8.** Six equidistant circumferential perianal wounds each closed with an absorbable suture (Monocryl 3/0).

location of all prostheses.

correct placement.

**Figure 5.** Palpating the IAS and the intersphincteric groove at the 6 o'clock position with a THD surgy Mini-light proc‐ toscope in position.

A 2mm incision is made in the perianal skin, 2 cm from the anal verge (Figure 6).

**Figure 6.** Making an incision, 2cm away from the anal verge, at the 6 o'clock position.

Having attached the dispenser to the delivery system, the needle is inserted through the incision and tunneled to the intersphincteric margin and introduced into the intersphincteric space. The needle is then positioned so that the tip would lie just beyond the dentate line. When the needle is identified in the correct position, by direct vision and palpation and/or by endoanal ultrasound, the prosthesis is released into the intersphincteric space (Figure 7).

The steps may be repeated to insert between four to six prostheses, equidistant from each other. The choice of inserting 4 as opposed to 6 prostheses is arbitrary. The wounds are closed with a single absorbable suture (Figure 8). At the end of procedure, EAUS imaging will show the location of all prostheses.

**Figure 5.** Palpating the IAS and the intersphincteric groove at the 6 o'clock position with a THD surgy Mini-light proc‐

Having attached the dispenser to the delivery system, the needle is inserted through the incision and tunneled to the intersphincteric margin and introduced into the intersphincteric space. The needle is then positioned so that the tip would lie just beyond the dentate line. When the needle is identified in the correct position, by direct vision and palpation and/or by endoanal ultrasound, the prosthesis is released into the intersphincteric space (Figure 7).

A 2mm incision is made in the perianal skin, 2 cm from the anal verge (Figure 6).

**Figure 6.** Making an incision, 2cm away from the anal verge, at the 6 o'clock position.

toscope in position.

132 Fecal Incontinence - Causes, Management and Outcome

**Figure 7.** THD Gatekeeper needle at the 9 o'clock position, with the endoanal ultrasound probe in place to determine correct placement.

**Figure 8.** Six equidistant circumferential perianal wounds each closed with an absorbable suture (Monocryl 3/0).

The procedure takes about 30 to 40 minutes to complete, and is done as a day-case. Oral metronidazole 400mg tds is prescribed for 5 days postoperatively. Oral laxatives such as lactulose are prescribed to minimize the risk of constipation. The patients are advised to avoid any anal trauma as well as anal intercourse for at least 72 h after implant insertion.

sacral nerve stimulation (SNS). The median follow up was of 18 months in the Gatekeeper group and 20 months in the SNS group. The authors reported a sustained improvement in the

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The results of the author's first 5 patients using this novel technique were evaluated. One was male and 4 were female. Four had idiopathic FI and one had passive incontinence following anal strech for anal fissure. All patients had failed conservative management. There was a significant impovement in median Vaizey scores at 6 months (16 vs 4, p<0.01). One patient, who was assessed at 12 months, had a sustained score improvement from 14 at baseline to 3

The development of anal injectable and implantable technology over the past 20 years has taken great strides forwards. Starting with the pioneering efforts of Shafik with autologous fat, more materials have been tried and used, the more popular being Collagen (Permacol) and Silicone (PTQ or Bioplastique). These agents were associated with variable and inconsistent results. Injections were frequently repeated to maintain continence long term. The latest generation of anal bulking agents is the implantable Hyexpan (THD Gatekeeper). This material fits the criteria for the 'ideal' bulking agent. It overcomes most limitations of other bulking agents, and its use has shown very promising initial results. Whether these results are

The mechanism of action of anal bulking agents is a subject of debate. Most of the resting anal pressure is the function of the IAS, with some contribution from the EAS and anal cushions. Studies of faecal incontinence in patients who have undergone a traditional Milligan Morgan haemorrhoidectomy lend support the concept that anal cushions play an important part in the maintenance of the normal mechanism of continence. It is thought that the mechanism of action of a bulking agent injected into the submucosal space is an increase in the size of the natural anal cushions. On the other hand, a bulking agent injected or implanted into the intersphinc‐ teric space would bulk the size of the anal sphincter. The end result would be an improvement in the seal of the lumen of the anal canal at rest and potentially an increase in resting anal pressure and in the length of the anal high pressure zone. When the injection is placed adjacent to an identifiable IAS defect, a better degree of anal canal sealing may be obtained through

It is acknowledged that more research required in this field. Most studies are case series with

Larger series with longer follow up and randomised controlled trials are therefore necessary.

Wexner continence scores with both modalities of treatment.

maintained in the longer term or not awaits to be seen.

improvement in the configuration and symmetry of the anal canal [7].

Further development on existing and emerging technology is also warranted.

**3. Discussion**

very few randomised trials.

at 3, 6 and 12 months. There have not been any complications to date.

The patients are followed up after 6 weeks and 3 monthly thereafter.

The material remains identifiable both by palpation and by endoanal ultrasonography in the postoperative period (Figure 9).

**Figure 9.** Endoanal ultrasound scan at 6 weeks following the implantation of four Gatekeeper prostheses (arrows) in a 72 year old male with idiopathic passive faecal incontinence.

Results:

The first reported experience with the THD Gatekeeper was by Ratto et al in 2011 [19]. This was a study with 14 patients. Eight had idiopathic FI, 4 had an IAS defect and 2 had combined IAS and EAS defects. The median follow-up was of 12 months (range 5 to 48 months). The authors reported a clinically significant improvement in continence in 13 patients, a sustained significant improvement in the Wexner and Vaizey scores and in the SF36 and FIQL quality of life scores. No complications have been reported.

The second study was a comparative retrospective study by Parello et al in 2012 [20]. Seven patients who had the THD Gatekeeper implanted were compared to 6 patients who underwent sacral nerve stimulation (SNS). The median follow up was of 18 months in the Gatekeeper group and 20 months in the SNS group. The authors reported a sustained improvement in the Wexner continence scores with both modalities of treatment.

The results of the author's first 5 patients using this novel technique were evaluated. One was male and 4 were female. Four had idiopathic FI and one had passive incontinence following anal strech for anal fissure. All patients had failed conservative management. There was a significant impovement in median Vaizey scores at 6 months (16 vs 4, p<0.01). One patient, who was assessed at 12 months, had a sustained score improvement from 14 at baseline to 3 at 3, 6 and 12 months. There have not been any complications to date.

#### **3. Discussion**

The procedure takes about 30 to 40 minutes to complete, and is done as a day-case. Oral metronidazole 400mg tds is prescribed for 5 days postoperatively. Oral laxatives such as lactulose are prescribed to minimize the risk of constipation. The patients are advised to avoid

The material remains identifiable both by palpation and by endoanal ultrasonography in the

**Figure 9.** Endoanal ultrasound scan at 6 weeks following the implantation of four Gatekeeper prostheses (arrows) in

The first reported experience with the THD Gatekeeper was by Ratto et al in 2011 [19]. This was a study with 14 patients. Eight had idiopathic FI, 4 had an IAS defect and 2 had combined IAS and EAS defects. The median follow-up was of 12 months (range 5 to 48 months). The authors reported a clinically significant improvement in continence in 13 patients, a sustained significant improvement in the Wexner and Vaizey scores and in the SF36 and FIQL quality

The second study was a comparative retrospective study by Parello et al in 2012 [20]. Seven patients who had the THD Gatekeeper implanted were compared to 6 patients who underwent

a 72 year old male with idiopathic passive faecal incontinence.

of life scores. No complications have been reported.

Results:

any anal trauma as well as anal intercourse for at least 72 h after implant insertion.

The patients are followed up after 6 weeks and 3 monthly thereafter.

postoperative period (Figure 9).

134 Fecal Incontinence - Causes, Management and Outcome

The development of anal injectable and implantable technology over the past 20 years has taken great strides forwards. Starting with the pioneering efforts of Shafik with autologous fat, more materials have been tried and used, the more popular being Collagen (Permacol) and Silicone (PTQ or Bioplastique). These agents were associated with variable and inconsistent results. Injections were frequently repeated to maintain continence long term. The latest generation of anal bulking agents is the implantable Hyexpan (THD Gatekeeper). This material fits the criteria for the 'ideal' bulking agent. It overcomes most limitations of other bulking agents, and its use has shown very promising initial results. Whether these results are maintained in the longer term or not awaits to be seen.

The mechanism of action of anal bulking agents is a subject of debate. Most of the resting anal pressure is the function of the IAS, with some contribution from the EAS and anal cushions. Studies of faecal incontinence in patients who have undergone a traditional Milligan Morgan haemorrhoidectomy lend support the concept that anal cushions play an important part in the maintenance of the normal mechanism of continence. It is thought that the mechanism of action of a bulking agent injected into the submucosal space is an increase in the size of the natural anal cushions. On the other hand, a bulking agent injected or implanted into the intersphinc‐ teric space would bulk the size of the anal sphincter. The end result would be an improvement in the seal of the lumen of the anal canal at rest and potentially an increase in resting anal pressure and in the length of the anal high pressure zone. When the injection is placed adjacent to an identifiable IAS defect, a better degree of anal canal sealing may be obtained through improvement in the configuration and symmetry of the anal canal [7].

It is acknowledged that more research required in this field. Most studies are case series with very few randomised trials.

Larger series with longer follow up and randomised controlled trials are therefore necessary. Further development on existing and emerging technology is also warranted.

#### **Author details**

John Camilleri-Brennan1,2\*

Address all correspondence to: johncbrennan@doctors.org.uk

1 Department of Surgery, Forth Valley Royal Hospital, Larbert, Stirlingshire, Scotland

[12] Watson NFS, Koshy A and Sagar PM. Anal bulking agents for faecal incontinence.

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137

[13] Tjandra JJ, Lim JF, Hiscock R, Rajendra P. Injectable silicone biomaterial for fecal in‐ continence caused by internal l sphincter dysfunction is effective. Dis Colon Rectum

[14] Tjandra JJ, Chan MK, Yeh HC. Injectable silicone biomaterial (PTQ) is more effective than carbon-coated beads (Durasphere) in treating passive faecal incontinence-a

[15] Siproudhis L, Morcet J, Laine F. Elastomer implants in faecal incontinence: a blind, randomized placebo-controlled study. Alimentary Pharmacology & Therapeutics

[16] Graf W, Mellgren A, Matzel KE, Hull T, Johansson C, Bernstein M, et al. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a

[17] Maeda Y, Vaizey CJ, Kamm MA. Pilot study of two new injectable bulking agents for the treatment of faecal incontinence. Colorectal Disease 2008; 10(3):268–72.

[18] van Wunnik B, Driessen A, Baeten C. Local giant cell foreign body reaction after sili‐ cone injection for fecal incontinence in humans: two case reports. Tech Coloproctol

[19] Ratto C, Parello A, Donisi L, Litta F, De Simone V, Spazzafumo L, Giordano P. Novel bulking agent for faecal incontinence. British Journal of Surgery 2011; 98 (11): 1644–

[20] Parello A, De Simone V, Donisi L, Litta F, Zaccone, Ratto C. Can Gatekeper, a new bulking agent be equivalent to SNS in patients with fecal incontinence in the pres‐

ence of only internal sphincter defects. Tech Coloproctol 2012. 16:77

randomised, sham-controlled trial. *Lancet* 2011;377(9770): 997–1003.

Colorectal Disease 2012. 14 (Suppl. 3), 29–33.

randomized trial. Colorectal Disease 2009;11(4):382–9.

2004; 47: 2138–46.

2007;25(9): 1125–32.

2012. 16:395–397

52

2 University of Glasgow Medical School, Glasgow, Scotland

#### **References**


[12] Watson NFS, Koshy A and Sagar PM. Anal bulking agents for faecal incontinence. Colorectal Disease 2012. 14 (Suppl. 3), 29–33.

**Author details**

**References**

John Camilleri-Brennan1,2\*

136 Fecal Incontinence - Causes, Management and Outcome

Address all correspondence to: johncbrennan@doctors.org.uk

2 University of Glasgow Medical School, Glasgow, Scotland

lon Rectum 36:77-97, 1993.

tum. 2000; 43(1):9-17

2002.12:333–338

1626–8.

Surg 2005; 92: 521-7.

nence. Int Surg 1993; 78: 159–91.

nence. Dis Colon Rectum 1995; 38: 583–7.

incontinence grading systems. Gut Jan 1999; 44: 77 – 80.

nence in adults. Clinical Guideline 49 NICE 2007

1 Department of Surgery, Forth Valley Royal Hospital, Larbert, Stirlingshire, Scotland

[1] Vaizey CJ, Carapeti E, Cahill JA, and Kamm MA. Prospective comparison of faecal

[2] Jorge, J.M.N., Wexner, S.D.: Etiology and management of fecal incontinence. Dis. Co‐

[3] Rockwood TH, Church JM, Fleshman JW, et al. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rec‐

[4] Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I.

[5] National Institute for Clinical Excellence (NICE). The management of faecal inconti‐

[6] Lightner DJ. Review of the available urethral bulking agents. Curr Opin Urol

[7] Vaizey CJ, Kamm MA. Injectable bulking agents for treating faecal incontinence. Br J

[8] Shafik A. Polytetrafluoroethylene injection for the treatment of partial fecal inconti‐

[9] Shafik A. Perianal injection of autologous fat for treatment of sphincteric inconti‐

[10] Bernardi C, Favetta U, Pescatori M. Autologous fat injection for treatment of fecal in‐ continence: manometric and echographic essment. Plast Reconstr Surg 1998; 102:

[11] Maeda Y, Laurberg S, Norton C. Perianal injectable bulking agents as treatment for faecal incontinence in adults. Cochrane Database Syst Rev. 2010;(5):CD007959.

Conceptual framework and item selection. Med Care 1992; 30:473–83


**Chapter 9**

**Traumatic Cloaca**

Constantine P. Spanos

http://dx.doi.org/10.5772/57377

ders related to this condition.

years of suffering and diminished quality of life.

**1. Introduction**

Additional information is available at the end of the chapter

Traumatic cloacal deformities are a result of major obstetric injury; these usually occur after a fourth-degree perineal laceration. They occur in one in 5000 vaginal deliveries. [1] This deformity is characterized by three anatomic lesions: complete disruption of the perineal body, anterior defect of the internal and external anal sphincter, and loss of the distal rectovaginal and/or anovaginal septum. [2-4] Thus, a common genitourinary and gastroin‐ testinal outlet ensues, as in congenital cloaca. This is the cause of symptoms and disor‐

Resulting disorders are mostly functional. These patients suffer from severe incontinence to flatus, liquid and solid stool. Recurrent urinary tract and vaginal infection may also result. Sexual dysfunction is significant; patients often complain of dyspareunia [4] or refrain from sexual activity altogether. Partners are also affected. All these disorders may lead to psychological disorders and social distress associated with incapacitating incontinence as well as a sense of shame from the "deformity". [3-6] A nihilistic approach from both the patient and physicians may lead to delay in treatment, thus burdening the patient with

There are several reports and series in the literature describing techniques for repairing traumatic cloacal deformities. There is considerable variety regarding the use or not of flaps, the use or not of fecal diversion. In any case, repair of these deformities can be challeng‐ ing and complex, and patients may present years after the initial injury. Some may have

> © 2014 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

had a previous repair, thus adding difficulty to definitive correction.

#### **Chapter 9**

## **Traumatic Cloaca**

Constantine P. Spanos

Additional information is available at the end of the chapter

http://dx.doi.org/10.5772/57377

#### **1. Introduction**

Traumatic cloacal deformities are a result of major obstetric injury; these usually occur after a fourth-degree perineal laceration. They occur in one in 5000 vaginal deliveries. [1] This deformity is characterized by three anatomic lesions: complete disruption of the perineal body, anterior defect of the internal and external anal sphincter, and loss of the distal rectovaginal and/or anovaginal septum. [2-4] Thus, a common genitourinary and gastroin‐ testinal outlet ensues, as in congenital cloaca. This is the cause of symptoms and disor‐ ders related to this condition.

Resulting disorders are mostly functional. These patients suffer from severe incontinence to flatus, liquid and solid stool. Recurrent urinary tract and vaginal infection may also result. Sexual dysfunction is significant; patients often complain of dyspareunia [4] or refrain from sexual activity altogether. Partners are also affected. All these disorders may lead to psychological disorders and social distress associated with incapacitating incontinence as well as a sense of shame from the "deformity". [3-6] A nihilistic approach from both the patient and physicians may lead to delay in treatment, thus burdening the patient with years of suffering and diminished quality of life.

There are several reports and series in the literature describing techniques for repairing traumatic cloacal deformities. There is considerable variety regarding the use or not of flaps, the use or not of fecal diversion. In any case, repair of these deformities can be challeng‐ ing and complex, and patients may present years after the initial injury. Some may have had a previous repair, thus adding difficulty to definitive correction.

© 2014 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

#### **2. Etiology**

Traumatic cloaca is usually the result of obstetric injury. The most common injuries involved are third and fourth-degree perineal lacerations. Third-degree lacerations are characterized by disruption of the internal and external anal sphincter. In fourth-degree lacerations, disruption of the anal and/or rectal epithelium is included in addition to sphincter injury. Surgical correction of these types of injuries involves precise, layered approximation of damaged structures and tissues. Failure of repair may be a result of hematoma, infection or technical mishaps. Partial failure may result in a rectovaginal fistula; complete failure leads to a cloacal deformity. [8] Traumatic cloaca may occur if these obstetric injuries of this nature are not repaired, or after failure of surgical repair. This may be secondary to poor surgical technique or a complication such as infection and disruption of the layered repair.

The resulting deformity is three-dimensional absence of the perineal body, disruption of the sphincter complex and loss of the anovaginal/anorectal septum of varying length.

#### **3. Signs and symptoms**

Most, if not all, women with traumatic cloacae have severe incontinence to flatus, liquid and solid stool. These patients also suffer from sequelae of the communication of the gastrointes‐ tinal and genitourinary tract; namely, severe perineal skin irritation, as well as recurrent urinary tract and vaginal infections. Sexual function is seriously affected. Many patients complain of dyspareunia, and abstinence from sexual activity is not uncommon. Thus, spouses and sexual partners are also affected by this disorder.

**Figure 1.** Traumatic cloaca with small bridge of skin between anus and vagina.

**Figure 2.** Traumatic cloaca. Note the incomplete anovaginal septum.

Additional diagnostic tests can be performed but are not mandatory. Endoanal ultrasound can be utilized to define the degree of the external and internal anal sphincter defect. In most cases,

Traumatic Cloaca

141

http://dx.doi.org/10.5772/57377

Traumatic cloaca may lead to psychological disorders and social distress associated with incapacitating incontinence as well as a sense of shame from the "deformity". Many patients with this disorder isolate themselves socially and suffer from anxiety and depression. [3-6] A nihilistic approach from both the patient and physicians may lead to delay in treatment, thus burdening the patient with years of suffering and diminished quality of life.

#### **4. Diagnosis**

A careful obstetric history and detailed physical exam of the perineal area is enough to make the diagnosis of traumatic cloaca. Inspection reveals the diminution or absence of the perineal body and the common genitourinary-gastrointestinal outlet. (Fig1, 2) A digital exam will reveal the length of the remaining anovaginal/rectovaginal septum as well as the relationship of the cervix with the rectum. This will aid in planning the appropriate surgical repair. The examining physician will also note a significant decrease in resting anal sphincter tone as well as a marked loss of voluntary squeeze pressure.

**Figure 1.** Traumatic cloaca with small bridge of skin between anus and vagina.

**2. Etiology**

140 Fecal Incontinence - Causes, Management and Outcome

**3. Signs and symptoms**

**4. Diagnosis**

loss of voluntary squeeze pressure.

and sexual partners are also affected by this disorder.

Traumatic cloaca is usually the result of obstetric injury. The most common injuries involved are third and fourth-degree perineal lacerations. Third-degree lacerations are characterized by disruption of the internal and external anal sphincter. In fourth-degree lacerations, disruption of the anal and/or rectal epithelium is included in addition to sphincter injury. Surgical correction of these types of injuries involves precise, layered approximation of damaged structures and tissues. Failure of repair may be a result of hematoma, infection or technical mishaps. Partial failure may result in a rectovaginal fistula; complete failure leads to a cloacal deformity. [8] Traumatic cloaca may occur if these obstetric injuries of this nature are not repaired, or after failure of surgical repair. This may be secondary to poor surgical technique

The resulting deformity is three-dimensional absence of the perineal body, disruption of the

Most, if not all, women with traumatic cloacae have severe incontinence to flatus, liquid and solid stool. These patients also suffer from sequelae of the communication of the gastrointes‐ tinal and genitourinary tract; namely, severe perineal skin irritation, as well as recurrent urinary tract and vaginal infections. Sexual function is seriously affected. Many patients complain of dyspareunia, and abstinence from sexual activity is not uncommon. Thus, spouses

Traumatic cloaca may lead to psychological disorders and social distress associated with incapacitating incontinence as well as a sense of shame from the "deformity". Many patients with this disorder isolate themselves socially and suffer from anxiety and depression. [3-6] A nihilistic approach from both the patient and physicians may lead to delay in treatment, thus

A careful obstetric history and detailed physical exam of the perineal area is enough to make the diagnosis of traumatic cloaca. Inspection reveals the diminution or absence of the perineal body and the common genitourinary-gastrointestinal outlet. (Fig1, 2) A digital exam will reveal the length of the remaining anovaginal/rectovaginal septum as well as the relationship of the cervix with the rectum. This will aid in planning the appropriate surgical repair. The examining physician will also note a significant decrease in resting anal sphincter tone as well as a marked

burdening the patient with years of suffering and diminished quality of life.

sphincter complex and loss of the anovaginal/anorectal septum of varying length.

or a complication such as infection and disruption of the layered repair.

**Figure 2.** Traumatic cloaca. Note the incomplete anovaginal septum.

Additional diagnostic tests can be performed but are not mandatory. Endoanal ultrasound can be utilized to define the degree of the external and internal anal sphincter defect. In most cases, a significant defect of the anterior portion of both sphincters is present. Anal physiologic testing such as manometry documents the decrease in resting tone and squeeze pressure. Improve‐ ment in these parameters can be assessed after surgical repair of traumatic cloaca. Finally, transanal pudendal nerve stimulation provides evaluation of the neuromuscular integrity of the pelvic floor. [11] Pudendal nerve terminal motor latency can be used to predict the success of sphincteroplasty in incontinent patients with anterior sphincter defects. [12] Assessment of fecal incontinence can be performed with any number of validated tests such as the Cleveland Clinic Florida-Wexner Score or the St. Marks' incontinence score. [1, 13]

procedure is performed under general anaesthesia and the patient is placed in the prone-

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The planned incisions are marked on the skin, where an "X" is outlined across the perineum,

The skin incision is performed, and flaps are developed to the ischiorectal fossae bi-laterally. Dissection is then carried out in the ischiorectal fossa cephalad up to the level of the levator

The next step is division of the ano-vagial/rectovaginal septum. Initially, traction sutures are placed in the anal and vaginal mucosa. Then, the septum is divided with electrocautery, and dissection is carried out cephalad up to the level of the puborectalis muscle. (Fig 5) This division allows for mobilization of both the rectal and vaginal "tubes". During the following step, both edges of the sphincter complex are identified. Mobilization of the sphincter complex is performed lateral to medial. An overlapping sphincteroplasty was then done with interrupted sutures. At all times, a small retractor is placed in the anal canal, in order to prevent stenosis after repair. Midline approximation of the levators is performed with interrupted 2-0 poly‐ propylene sutures, thus filling the space between the anal and vaginal tubes and re-creating a perineal "body". Overlapping of the "X" flaps is then undertaken. The anterior wall of the anus and the posterior wall of the vagina are sutured to the skin of the newly constructed perineum. Layered closure with absorbable sutures is performed. (Fig 6) No drains are placed,

Postoperatively, betadine ointment is applied to the wounds daily. Metronidazole is given orally for 7 days. Patients are allowed moderate ambulation immediately; however, sitting is

jacknife position with the buttocks taped apart and a urinary catheter in place.

intersecting at the point of the anovaginal septum. (Fig 3)

muscles. (Fig 4)

**Figure 3.** Outline of "X" incision on perineum.

and we do not routinely create a diverting stoma.

#### **5. Treatment**

Women with a traumatic cloaca defect are incapacitated in many aspects. Severe incontinence may lead to social isolation. Sexual dysfunction may result in depression and other psycho‐ logical disorders. Both the patient and the obstetrician may be unaware that such defects can be repaired; therefore, traumatic cloaca may go untreated for many years.

The mainstay of conservative treatment is manipulation of stool consistency and frequency. This is done with fiber bulking and constipating medication such as loperamide. While this type of therapy is valid, results are not satisfactory. The anatomic defects that are associated with traumatic cloaca are such that severe incontinence persists despite conservative therapy. Surgical correction is usually necessary.

#### **6. Surgical treatment**

A variety of surgical techniques have been utilized to repair traumatic cloaca.

Surgical correction of these defects invariably involves the following steps:


#### **6.1. Perineoplasty with X-flaps**

This surgical technique was originally described by Corman [6] and was used both for traumatic cloaca repair as well as rectovaginal fistula repair. It is the technique most commonly used at our institution.

Preoperatively, all patients are given a full bowel preparation. Intravenous broad-spectrum antibiotics are administered preoperatively and continued for 24 hours post-surgery. The procedure is performed under general anaesthesia and the patient is placed in the pronejacknife position with the buttocks taped apart and a urinary catheter in place.

The planned incisions are marked on the skin, where an "X" is outlined across the perineum, intersecting at the point of the anovaginal septum. (Fig 3)

The skin incision is performed, and flaps are developed to the ischiorectal fossae bi-laterally. Dissection is then carried out in the ischiorectal fossa cephalad up to the level of the levator muscles. (Fig 4)

a significant defect of the anterior portion of both sphincters is present. Anal physiologic testing such as manometry documents the decrease in resting tone and squeeze pressure. Improve‐ ment in these parameters can be assessed after surgical repair of traumatic cloaca. Finally, transanal pudendal nerve stimulation provides evaluation of the neuromuscular integrity of the pelvic floor. [11] Pudendal nerve terminal motor latency can be used to predict the success of sphincteroplasty in incontinent patients with anterior sphincter defects. [12] Assessment of fecal incontinence can be performed with any number of validated tests such as the Cleveland

Women with a traumatic cloaca defect are incapacitated in many aspects. Severe incontinence may lead to social isolation. Sexual dysfunction may result in depression and other psycho‐ logical disorders. Both the patient and the obstetrician may be unaware that such defects can

The mainstay of conservative treatment is manipulation of stool consistency and frequency. This is done with fiber bulking and constipating medication such as loperamide. While this type of therapy is valid, results are not satisfactory. The anatomic defects that are associated with traumatic cloaca are such that severe incontinence persists despite conservative therapy.

Clinic Florida-Wexner Score or the St. Marks' incontinence score. [1, 13]

be repaired; therefore, traumatic cloaca may go untreated for many years.

A variety of surgical techniques have been utilized to repair traumatic cloaca.

**1.** Separation of the anorectum from the vagina by dissecting the rectovaginal septum.

**2.** Performance of an overlapping sphincteroplasty using both the external and internal anal

**3.** Reconstruction of the perineal body by plicating the puborectalis muscle to the midline

This surgical technique was originally described by Corman [6] and was used both for traumatic cloaca repair as well as rectovaginal fistula repair. It is the technique most commonly

Preoperatively, all patients are given a full bowel preparation. Intravenous broad-spectrum antibiotics are administered preoperatively and continued for 24 hours post-surgery. The

Surgical correction of these defects invariably involves the following steps:

sphincter, thus repairing the anterior defect.

**5. Treatment**

Surgical correction is usually necessary.

142 Fecal Incontinence - Causes, Management and Outcome

**6. Surgical treatment**

and skin closure.

used at our institution.

**6.1. Perineoplasty with X-flaps**

The next step is division of the ano-vagial/rectovaginal septum. Initially, traction sutures are placed in the anal and vaginal mucosa. Then, the septum is divided with electrocautery, and dissection is carried out cephalad up to the level of the puborectalis muscle. (Fig 5) This division allows for mobilization of both the rectal and vaginal "tubes". During the following step, both edges of the sphincter complex are identified. Mobilization of the sphincter complex is performed lateral to medial. An overlapping sphincteroplasty was then done with interrupted sutures. At all times, a small retractor is placed in the anal canal, in order to prevent stenosis after repair. Midline approximation of the levators is performed with interrupted 2-0 poly‐ propylene sutures, thus filling the space between the anal and vaginal tubes and re-creating a perineal "body". Overlapping of the "X" flaps is then undertaken. The anterior wall of the anus and the posterior wall of the vagina are sutured to the skin of the newly constructed perineum. Layered closure with absorbable sutures is performed. (Fig 6) No drains are placed, and we do not routinely create a diverting stoma.

Postoperatively, betadine ointment is applied to the wounds daily. Metronidazole is given orally for 7 days. Patients are allowed moderate ambulation immediately; however, sitting is

**Figure 4.** Flaps have been developed, and dissection up to the level of the puborectalis (arrow) is performed.

discouraged. Pharmacological bowel confinement is achieved by administering loperamide thrice daily for 5 days. A soft diet is started on the second postoperative day. Fiber supplements are given after discontinuation of loperamide.

**Figure 6.** Completed repair, with separation of anus and vagina and restoration of perineal body.

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**Figure 7.** Repair at one month after surgical correction.

**Figure 5.** Divided anovaginal septum, with posterior vaginal wall superiorly.

**Figure 6.** Completed repair, with separation of anus and vagina and restoration of perineal body.

**Figure 7.** Repair at one month after surgical correction.

discouraged. Pharmacological bowel confinement is achieved by administering loperamide thrice daily for 5 days. A soft diet is started on the second postoperative day. Fiber supplements

**Figure 4.** Flaps have been developed, and dissection up to the level of the puborectalis (arrow) is performed.

are given after discontinuation of loperamide.

144 Fecal Incontinence - Causes, Management and Outcome

**Figure 5.** Divided anovaginal septum, with posterior vaginal wall superiorly.

#### **6.2. Transverse to vertical incision**

An alternative technique, especially in patients with a low-profile perineum, (Fig 8) utilizes a transverse incision, made between the anus and vagina. This incision may also be curvilinear. Dissection of the ischiorectal fossae, division of the anovaginal septum, levatoroplasty and overlapping sphincteroplasty are performed in a fashion similar to the patients with the "X" flaps. The transverse incision is closed in a vertical fashion, thus creating a high-profile perineum. (Fig 9)

**7. Results of surgical correction**

and cosmetic result.

perineal body.

Despite the variety of techniques used in the correction of traumatic cloacal deformities, data on the outcome of these procedures is limited. Most reports are based on small series of

**Figure 9.** Postoperative photo of patient in previous figure. Result after vertical closure of incision, with restoration of

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The largest series of patients utilizing X-flaps for traumatic cloaca correction has been reported by Kaiser [4]. Twelve patients underwent this procedure in a 5-year period. No prophylactic diverting stomas were constructed. Three patients experienced postoperative rectovaginal fistula, and in one of these patients a stoma was necessary. Minor wound complications were observed in 8 patients. After surgical follow-up of 9.83 ± 2.8 months and long-term follow-up of 38.9 ± 6.9 months, all the patients were satisfied with regards to overall function, continence

In our own small series of 4 patients, mean hospital length stay was 5 ± 0.8 days (range 4-6). All patients were followed in the outpatient clinic weekly for the first month, then monthly for the next 3 months. Median follow-up was 27 months (range 10 – 52 months). One patient developed a small, superficial separation of the corner of the X-flap. This was resolved by placing sutures. One patient experienced significant constipation at 2 weeks postoperatively. This was treated with manual disimpaction and subsequent small-volume enemas. There were no wound infections, separation of the sphincter repair, or rectovaginal fistulas. At 1 month

patients; meta-analyses regarding results have not been performed.

post-repair there was excellent healing of all wounds. (Fig 7)

**Figure 8.** Patient with a low-profile perineum after obstetric injury. This patient underwent surgical correction utiliz‐ ing a transverse-to vertical perineal incision.

#### **6.3. Island flaps**

Instead of primary closure of the skin, which is used in the techniques mentioned previously, perineal closure can be achieved by using island skin flaps.

Draganic and Solomon have reported their experience with island flap perineoplasty and concluded that wound dehiscence was significantly lower when skin flaps rather than simple wound approximation was used for perineal closure. [7] In their series, they performed a faecal diversion in 75% of their patients.

**Figure 9.** Postoperative photo of patient in previous figure. Result after vertical closure of incision, with restoration of perineal body.

#### **7. Results of surgical correction**

**6.2. Transverse to vertical incision**

146 Fecal Incontinence - Causes, Management and Outcome

ing a transverse-to vertical perineal incision.

diversion in 75% of their patients.

perineal closure can be achieved by using island skin flaps.

**6.3. Island flaps**

perineum. (Fig 9)

An alternative technique, especially in patients with a low-profile perineum, (Fig 8) utilizes a transverse incision, made between the anus and vagina. This incision may also be curvilinear. Dissection of the ischiorectal fossae, division of the anovaginal septum, levatoroplasty and overlapping sphincteroplasty are performed in a fashion similar to the patients with the "X" flaps. The transverse incision is closed in a vertical fashion, thus creating a high-profile

**Figure 8.** Patient with a low-profile perineum after obstetric injury. This patient underwent surgical correction utiliz‐

Instead of primary closure of the skin, which is used in the techniques mentioned previously,

Draganic and Solomon have reported their experience with island flap perineoplasty and concluded that wound dehiscence was significantly lower when skin flaps rather than simple wound approximation was used for perineal closure. [7] In their series, they performed a faecal Despite the variety of techniques used in the correction of traumatic cloacal deformities, data on the outcome of these procedures is limited. Most reports are based on small series of patients; meta-analyses regarding results have not been performed.

The largest series of patients utilizing X-flaps for traumatic cloaca correction has been reported by Kaiser [4]. Twelve patients underwent this procedure in a 5-year period. No prophylactic diverting stomas were constructed. Three patients experienced postoperative rectovaginal fistula, and in one of these patients a stoma was necessary. Minor wound complications were observed in 8 patients. After surgical follow-up of 9.83 ± 2.8 months and long-term follow-up of 38.9 ± 6.9 months, all the patients were satisfied with regards to overall function, continence and cosmetic result.

In our own small series of 4 patients, mean hospital length stay was 5 ± 0.8 days (range 4-6). All patients were followed in the outpatient clinic weekly for the first month, then monthly for the next 3 months. Median follow-up was 27 months (range 10 – 52 months). One patient developed a small, superficial separation of the corner of the X-flap. This was resolved by placing sutures. One patient experienced significant constipation at 2 weeks postoperatively. This was treated with manual disimpaction and subsequent small-volume enemas. There were no wound infections, separation of the sphincter repair, or rectovaginal fistulas. At 1 month post-repair there was excellent healing of all wounds. (Fig 7)

At the latest follow-up visit, all patients reported significant improvement in fecal continence. The mean Cleveland Clinic Florida/Wexner score decreased from a mean preoperative value of 18.25 ± 0.95 to a postoperative value of 1.25 ±1.5. All patients required fibre supplement to maintain stool consistency. None of the patients required use of pads, and major incontinence episodes were ameliorated.

physicians may be unaware of the possibility of repair of such lesions and fail to refer to a

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Conservative measures and/or pharmacologic manipulation of bowel movements do not improve quality of life and is not a sustainable treatment modality for this condition. Surgical

As in our small series, other authors have reported prior attempts to repair either a perineal laceration or a cloacal deformity before definitive correction. [2, 4] The timing of this definitive repair is extremely important. Early surgical repair may lead to failure as a result of active inflammation and absence of dissection planes. Therefore, most experts advise a waiting time of at least 3 months after index injury or previous repair before correction is undertaken. [2, 6] Even though these lesions are rare, a variety of surgical techniques for correction have been described. [2-7] Most employ overlapping sphincteroplasty and division of the rectovaginal septum. Perineal body construction is performed in several ways. Closure at right angles to the original incision is one of the most common modes of perineal reconstruction. Others use island flaps or lotus petal flaps. [7, 10] Some authors advise partial closure of the wound, as to avoid wound infection, which is the most serious complication of cloacal repair. [2, 9]

Anovaginal and perineal reconstruction utilizing X flaps was initially described by Corman. [6] Kaiser reported a series of 12 patients in which improvement in fecal continence and sexual function was significant. [4] Possible downsides of this technique in comparison with others are the intrinsic complexity of the operation and potential problems with wound healing, specifically ischemia of the flaps. On the other hand, partial closure of a perineal wound may

We believe the most important technical point in correction of cloacal deformities is the division of the anovaginal/rectovaginal septum, with mobilization of the anorectal and vaginal tubes. Herein lays the potential for failure of the repair. Several points regarding this division

Firstly, meticulous hemostasis is mandatory. The vagina is an extremely vascular anatomical structure; large vessels (especially veins) surround it. A fair amount of bleeding may be encountered during anovaginal separation if an incorrect plane is entered. Hematoma formation with potential infection and abscess formation may lead to catastrophic results. Second, care should be taken not to "buttonhole" either the anorectum or vagina during this dissection. Unrepaired perforations in either structure may also lead to septic collections and failure of the operation. Third, interposition of tissue in the space created by the division must be utilized. This constructs a perineal body and supports the sphincteroplasty. It also fills dead space and eliminates the possibility of fluid collections, which, as mentioned before, may lead to failure. Plication of the puborectalis muscle seems to be the easiest choice of tissue for this interposition, since it is in immediate anatomical proximity. Other potential techniques should the puborectalis prove to be inadequate, are utilization of a bulbocarvernosus (Martius) flap, or a gracilis muscle flap. This could add significant complexity to the repair, however.

Some authors advocate construction of a temporary stoma. [1, 10] Proponents of fecal diversion maintain that this allows accelerated perineal healing and avoidance of infection and failure of the repair. The mechanics of defecation in the immediate perioperative period may also

take time to heal, and may require multiple dressing changes and visits to clinic.

specialist.

treatment is required.

are important.

Regarding sexual activity, all patients were empirically advised to resume vaginal intercourse 3 months after repair. All patients resumed activity; one patient complained of dyspareunia at the end of the follow-up period.

Venkatesh and Ramanujam [3] reported surgical correction of traumatic cloaca in 44 patients over a 14-year period. The technique involved approximation of the internal and external sphincters together with the transverse perineal muscles in a vest-over- pants manner. The transverse perineal incision was closed vertically. The authors reported excellent functional results with minimal morbidity. A diverting stoma was not performed. Dyspareunia was reported in 27% of patients.

Excellent functional results have been also reported by Abcarian et al. [2] Their group per‐ formed surgical correction in 43 patients. Anal physiological testing was done preoperatively and postoperatively; most parameters (resting tone and voluntary squeeze pressures) return to normal after surgery.

Hollingshead et al reported on their experience in repairing traumatic cloacal deformities. [1] Twenty-nine patients underwent surgical repair over a 14-year period. The technique em‐ ployed a curvilinear incision, division of the anovaginal septum, identification and mobiliza‐ tion of the cut sphincter edges. Then the anorectal defect was closed, a sphincteroplasty performed and the vagina repaired. In this series, the puborectalis or levator muscles were not plicated, and the initial incision was closed longitudinally. A stoma was constructed in 13 patients. Two out of 12 patients in whom a stoma was not fashioned at the time of repair developed a rectovaginal fistula and required subsequent bowel defunctioning. In most patients, improvement in incontinence scores, anophysiologic testing and sexual function.

#### **8. Discussion**

Traumatic cloacal deformities are rare post-obstetric injuries characterized by diminution or disruption of the perineal body, anterior division and lateral retraction of the anal sphincters, and loss of the distal ano/rectovaginal septum of varying length. [1-6]

These deformities may be a result of a third or fourth degree perineal laceration, which may or may not have been repaired. Failure of repair may be a result of hematoma, infection or technical mishaps. Partial failure may result in a rectovaginal fistula; complete failure leads to a cloacal deformity. [8]

Most, if not all patients have complete loss of defecatory control. This leads to skin irritation, genitourinary infections and a significant degree of sexual dysfunction.

The effect on the quality of life of these patients is profound. Patients feel "deformed", and may isolate themselves. Medical advice may be deferred for years. On the other hand, physicians may be unaware of the possibility of repair of such lesions and fail to refer to a specialist.

At the latest follow-up visit, all patients reported significant improvement in fecal continence. The mean Cleveland Clinic Florida/Wexner score decreased from a mean preoperative value of 18.25 ± 0.95 to a postoperative value of 1.25 ±1.5. All patients required fibre supplement to maintain stool consistency. None of the patients required use of pads, and major incontinence

Regarding sexual activity, all patients were empirically advised to resume vaginal intercourse 3 months after repair. All patients resumed activity; one patient complained of dyspareunia

Venkatesh and Ramanujam [3] reported surgical correction of traumatic cloaca in 44 patients over a 14-year period. The technique involved approximation of the internal and external sphincters together with the transverse perineal muscles in a vest-over- pants manner. The transverse perineal incision was closed vertically. The authors reported excellent functional results with minimal morbidity. A diverting stoma was not performed. Dyspareunia was

Excellent functional results have been also reported by Abcarian et al. [2] Their group per‐ formed surgical correction in 43 patients. Anal physiological testing was done preoperatively and postoperatively; most parameters (resting tone and voluntary squeeze pressures) return

Hollingshead et al reported on their experience in repairing traumatic cloacal deformities. [1] Twenty-nine patients underwent surgical repair over a 14-year period. The technique em‐ ployed a curvilinear incision, division of the anovaginal septum, identification and mobiliza‐ tion of the cut sphincter edges. Then the anorectal defect was closed, a sphincteroplasty performed and the vagina repaired. In this series, the puborectalis or levator muscles were not plicated, and the initial incision was closed longitudinally. A stoma was constructed in 13 patients. Two out of 12 patients in whom a stoma was not fashioned at the time of repair developed a rectovaginal fistula and required subsequent bowel defunctioning. In most patients, improvement in incontinence scores, anophysiologic testing and sexual function.

Traumatic cloacal deformities are rare post-obstetric injuries characterized by diminution or disruption of the perineal body, anterior division and lateral retraction of the anal sphincters,

These deformities may be a result of a third or fourth degree perineal laceration, which may or may not have been repaired. Failure of repair may be a result of hematoma, infection or technical mishaps. Partial failure may result in a rectovaginal fistula; complete failure leads to

Most, if not all patients have complete loss of defecatory control. This leads to skin irritation,

The effect on the quality of life of these patients is profound. Patients feel "deformed", and may isolate themselves. Medical advice may be deferred for years. On the other hand,

and loss of the distal ano/rectovaginal septum of varying length. [1-6]

genitourinary infections and a significant degree of sexual dysfunction.

episodes were ameliorated.

reported in 27% of patients.

to normal after surgery.

**8. Discussion**

a cloacal deformity. [8]

at the end of the follow-up period.

148 Fecal Incontinence - Causes, Management and Outcome

Conservative measures and/or pharmacologic manipulation of bowel movements do not improve quality of life and is not a sustainable treatment modality for this condition. Surgical treatment is required.

As in our small series, other authors have reported prior attempts to repair either a perineal laceration or a cloacal deformity before definitive correction. [2, 4] The timing of this definitive repair is extremely important. Early surgical repair may lead to failure as a result of active inflammation and absence of dissection planes. Therefore, most experts advise a waiting time of at least 3 months after index injury or previous repair before correction is undertaken. [2, 6]

Even though these lesions are rare, a variety of surgical techniques for correction have been described. [2-7] Most employ overlapping sphincteroplasty and division of the rectovaginal septum. Perineal body construction is performed in several ways. Closure at right angles to the original incision is one of the most common modes of perineal reconstruction. Others use island flaps or lotus petal flaps. [7, 10] Some authors advise partial closure of the wound, as to avoid wound infection, which is the most serious complication of cloacal repair. [2, 9]

Anovaginal and perineal reconstruction utilizing X flaps was initially described by Corman. [6] Kaiser reported a series of 12 patients in which improvement in fecal continence and sexual function was significant. [4] Possible downsides of this technique in comparison with others are the intrinsic complexity of the operation and potential problems with wound healing, specifically ischemia of the flaps. On the other hand, partial closure of a perineal wound may take time to heal, and may require multiple dressing changes and visits to clinic.

We believe the most important technical point in correction of cloacal deformities is the division of the anovaginal/rectovaginal septum, with mobilization of the anorectal and vaginal tubes. Herein lays the potential for failure of the repair. Several points regarding this division are important.

Firstly, meticulous hemostasis is mandatory. The vagina is an extremely vascular anatomical structure; large vessels (especially veins) surround it. A fair amount of bleeding may be encountered during anovaginal separation if an incorrect plane is entered. Hematoma formation with potential infection and abscess formation may lead to catastrophic results. Second, care should be taken not to "buttonhole" either the anorectum or vagina during this dissection. Unrepaired perforations in either structure may also lead to septic collections and failure of the operation. Third, interposition of tissue in the space created by the division must be utilized. This constructs a perineal body and supports the sphincteroplasty. It also fills dead space and eliminates the possibility of fluid collections, which, as mentioned before, may lead to failure. Plication of the puborectalis muscle seems to be the easiest choice of tissue for this interposition, since it is in immediate anatomical proximity. Other potential techniques should the puborectalis prove to be inadequate, are utilization of a bulbocarvernosus (Martius) flap, or a gracilis muscle flap. This could add significant complexity to the repair, however.

Some authors advocate construction of a temporary stoma. [1, 10] Proponents of fecal diversion maintain that this allows accelerated perineal healing and avoidance of infection and failure of the repair. The mechanics of defecation in the immediate perioperative period may also potentially lead to disruption of the puborectalis plication or other tissue interposition. Stomas are associated with significant morbidity (skin irritation, prolapse, hernia), and need a second operation for closure. [8, 9] In addition, they do not seem to improve outcomes. Some experts reserve diversion for major failure of the perineal repair. [3, 4]

[2] Abcarian H, Orsay CP, Pearl RK, et al. Traumatic cloaca. Dis Colon Rectum

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[3] Venkatesh KS, Ramanujam P. Surgical treatment of traumatic cloaca. Dis Colon Rec‐

[4] Kaiser AM. Cloaca-like deformity with fecal incontinence after after severe obstetric injury-technique and functional outcome of ano-vaginal and perineal reconstruction

[5] Mercês RL, Pisi PH, Balestrim Fo A, et al. Surgical treatment of traumatic cloaca. Acta

[6] Corman, ML. Anal incontinence following obstetrical injury. Dis Colon Rectum

[7] Draganic B, Solomon MJ. Island flap perineoplasty for coverage of perineal skin de‐

[8] Spanos CP, Mikos T, Kastanias E, et al. Surgical treatment of traumatic cloaca. Arch

[9] Valente MA, Khanduja KS. Layered surgical repair of traumatic cloacal deformities: technical details and functional outcomes. Tech Coloproctol 2012; 16:153-156

[10] Altomare DF, Rinaldi M, Bucaria V, et al. Overlapping sphincteroplasty and modi‐ fied lotus petal flap for delayed repair of traumatic cloaca. Tech Coloproctol 2007;

[11] Kiff ES, Swash M. Slowed conduction in the pudendal nerves in idiopathic (neuro‐

[12] Wexner SD, Marchetti F, Jagelman DG. The role of sphincteroplasty for fecal inconti‐ nence reevaluated: prospective physiologic and functional review. Dis Colon Rectum

[13] Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon

with X-flaps and sphincteroplasty. Colorectal Dis 2008;10:827-832

fects after repair of cloacal deformity. ANZ J Surg 2001;71:487-490

1989;32:783-787

1985;28 :86-89

11:268-270

1996; 39:1164-70

Rectum 1993; 36:77-97

tum 1996;39:811-816

Cir Bras 2008; 23 Suppl 1, 1:105-107

Gynecol Obstet 2012;286:815-818

genic) fecal incontinence. Br J Surg 1984; 71:614-16

The most common complications reported after correction of traumatic cloacal deformities are minor wound infection, rectovaginal fistula and breakdown of the perineal wound. These may occur in up to 40% of cases [1]. Expectant therapy and revision of repair are utilized in these instances [1, 4]

After definitive correction of traumatic cloacal deformities, sexual activity and subsequent pregnancies should be deferred; however, the exact "safe" time period remains to be deter‐ mined. Some authors advise sexual abstinence for at least 6 weeks post repair. [8] Caesarean section after complex perineal repairs seems reasonable.

Finally, improvement in fecal incontinence is significant following cloacal repair in most series even after long-term follow-up. [1, 3, 4].

#### **9. Conclusion — Summary**

Traumatic cloacal deformities are the least frequent complications of obstetric injuries to the anorectum. Repair and reconstruction of all anatomical structures involved is feasible with satisfactory cosmetic and functional results. Correction of these deformities can be performed using a variety of techniques. Careful dissection and division of the anovaginal/rectovaginal septum is a crucial step in the creation of a new perineal body. Referral to a specialist colorectal surgeon familiar with repair of traumatic cloacal deformities may improve the quality of life of patients. Fecal diversion is not mandatory.

#### **Author details**

Constantine P. Spanos\*

Address all correspondence to: costasspanos@hotmail.com

Department of Surgery, Aristotelian University, Thessaloniki, Greece

#### **References**

[1] Hollingshead JRF, Warusavitarne J, Vaizey CJ, Northover JMA. Outcomes following repair of traumatic cloacal deformities. Br J Surg 2009;96:1082-1085

[2] Abcarian H, Orsay CP, Pearl RK, et al. Traumatic cloaca. Dis Colon Rectum 1989;32:783-787

potentially lead to disruption of the puborectalis plication or other tissue interposition. Stomas are associated with significant morbidity (skin irritation, prolapse, hernia), and need a second operation for closure. [8, 9] In addition, they do not seem to improve outcomes. Some experts

The most common complications reported after correction of traumatic cloacal deformities are minor wound infection, rectovaginal fistula and breakdown of the perineal wound. These may occur in up to 40% of cases [1]. Expectant therapy and revision of repair are utilized in these

After definitive correction of traumatic cloacal deformities, sexual activity and subsequent pregnancies should be deferred; however, the exact "safe" time period remains to be deter‐ mined. Some authors advise sexual abstinence for at least 6 weeks post repair. [8] Caesarean

Finally, improvement in fecal incontinence is significant following cloacal repair in most series

Traumatic cloacal deformities are the least frequent complications of obstetric injuries to the anorectum. Repair and reconstruction of all anatomical structures involved is feasible with satisfactory cosmetic and functional results. Correction of these deformities can be performed using a variety of techniques. Careful dissection and division of the anovaginal/rectovaginal septum is a crucial step in the creation of a new perineal body. Referral to a specialist colorectal surgeon familiar with repair of traumatic cloacal deformities may improve the quality of life

[1] Hollingshead JRF, Warusavitarne J, Vaizey CJ, Northover JMA. Outcomes following

repair of traumatic cloacal deformities. Br J Surg 2009;96:1082-1085

reserve diversion for major failure of the perineal repair. [3, 4]

section after complex perineal repairs seems reasonable.

even after long-term follow-up. [1, 3, 4].

150 Fecal Incontinence - Causes, Management and Outcome

of patients. Fecal diversion is not mandatory.

Address all correspondence to: costasspanos@hotmail.com

Department of Surgery, Aristotelian University, Thessaloniki, Greece

**9. Conclusion — Summary**

**Author details**

**References**

Constantine P. Spanos\*

instances [1, 4]


**Chapter 10**

**Medical and Surgical Management of Fecal Incontinence**

Fecal incontinence is a socially distressing misfortunate condition, which can be very embar‐ rassing. It affects children, with dramatic behavioral and personality changes, with patients becoming socially withdrawn and reluctant to leave their homes. Victims are housebound and become socially disruptive. This condition may be due to (1) congenital anorectal malforma‐ tions (2) trauma to anal sphincter (3) injuries to the sphincter following operations on the anal

It can occur from a variety of conditions. The most common is overflow incontinence from functional fecal retention, but it can also occur in otherwise healthy children with functional nonretentive fecal soiling or in children with organic causes of fecal incontinence, such as congenital malformations, or any other condition affecting the anorectum, anal sphincters, or

Mild to moderate incontinence, when there is no injury to the sphincters, can be treated by dietary modification, pharmacological treatment and behavioral therapy. Dietary modifica‐ tion entails having foods with high fiber content such as fruits, vegetables, beans and whole wheat bread. Pharmacological treatment includes prescription of synthetic cellulose and psyllium husk derived from the plantago tree, and antidiarrhea drugs such as Loperamide, diphenoxylate hydrochloride and codeine phosphate. Behavioral therapy techniques involve toilet training; urge control strategies, as well as pelvic floor physical therapy and biofeedback.

Surgical management of fecal incontinence should be reserved for patients with identifiable anal sphincter defects. It includes sphincteroplasty, which is indicated for sphincter disruption after surgical procedures, and muscle transpositions procedures, that are recommended when anal incontinence is secondary to anal sphincter disruption unresponsive to repair, neurogenic

> © 2014 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

**after Repair of High Imperforate Anus Anomalies**

Talal Abdallah Al-Malki

**1. Introduction**

the spinal cord.

Additional information is available at the end of the chapter

canal and (4) central nervous disease or nerve injury.
