*3.1.2.2 Efficacy and safety profile*

*Recent Advances in Laparoscopic Surgery*

*3.1.1.2 Efficacy and safety profile*

treatment to 33.1 kg/m2

, which dropped to 33.1 kg/m2

and future applications remain uncertain.

*3.1.2 Endoscopic sleeve gastroplasty (ESG)*

41.5 kg/m2

*3.1.2.1 Technique*

to the lesser curvature. This step is repeated until one has created a sleeve of the desired length. The sleeve outlet is then narrowed using the TOGA restrictor.

The first human study assessing the safety and efficacy of the TOGA system took place in 2008, in which 21 morbidly obese individuals with a mean BMI of 43.4 kg/m2 were enrolled [15]. After 6 months, patients had an average EWL of 24.4%. No serious adverse events (SAE) were reported. However, at 6 month follow-up endoscopy, gaps in the staple line were observed in 13 out of 21 patients. After technical improvements of the device, a second human pilot study enrolled 11 patients who met criteria for bariatric surgery [14]. Average BMI decreased significantly from 41.6 kg/m2

ticenter trial with 1-year outcome, which involved 67 patients with a mean BMI of

A small case study evaluating the effect of TOGA on insulin sensitivity and secretion even demonstrated an amelioration of insulin sensitivity with subsequent reduction of the insulin secretion [17]. Compared to the more effective laparoscopic gastric bypass and biliopancreatic diversion, the TOGA system reached a good therapeutic outcome in terms of weight loss and showed no complications [18]. Based on the evidence available, TOGA has showed to be a feasible and effective procedure to treat obesity with a promising potential for the future. However, a multicenter randomized FDA trial was terminated secondary to lack of efficacy, whereafter the company dissolved,

Another system to create a restrictive sleeve is the Overstitch system (Apollo Endosurgery, Austin, Texas, USA). Contrary to the TOGA system, it applies fullthickness running sutures alongside the greater curvature of the stomach. This results in a reduction of the functional capacity of the stomach by up to 70%, a size comparable to the reduction of the gastric lumen in laparoscopic sleeve gastrectomy (LSG) [19]. This device is currently commercially available in the United States.

The Overstitch system (**Figure 3**) consists of a double-channel endoscope equipped with a mounted suturing platform. To ensure full-thickness suture placement, a tissue grasper device is used to mobilize and capture the desired location of the suture at the gastric wall, whereafter the tissue is retracted into the suturing arm of the device [20]. As the evolution of the ESG evolved over time, different

*The Overstitch system and full-thickness suture placement (from ApolloEndosurgery®, with permission).*

at 6 month follow-up. The same results were seen in a mul-

at 6 months after the TOGA procedure [16].

before

**40**

**Figure 3.**

After the Mayo Clinic first demonstrated the clinical safety and feasibility of this technique in early 2013, multiple studies have confirmed the safety and efficacy of this procedure. A multicenter study among 3 centers, including 248 subjects with a baseline BMI of 37.8 ± 5.6 kg/m<sup>2</sup> , showed a total body weight loss (TBWL) of 15.2% [95%CI 14.2–16.3] and 18.6% [15.7–21.5], at, respectively, 6 and 24 month follow-up [23]. Five (2%) serious adverse events occurred: two patients presented with perigastric inflammatory fluid collection which resolved with percutaneous drainage and antibiotics, one patient presented with self-limiting hemorrhage due to marginal splenic laceration, one patient with a pulmonary embolism 72 h postoperative, and one patient required placement of a chest tube to treat concomitant pneumoperitoneum and pneumothorax caused during the procedure. All patients recovered without the need of surgical intervention. A recent retrospective analysis among 112 obese patients (baseline BMI 37.9 ± 6.7 kg/m<sup>2</sup> ) who underwent ESG using the Overstitch device reported comparable and consistent findings of approximately 15% TBWL and 50% EWL at 6 month post-ESG [24]. In the prospective study of Sharaiha et al., ESG accounted for a reduction in markers of hypertension, diabetes, and hypertriglyceridemia in addition to sustained total body weight loss after a period of 24 months [25]. ESG appears to be safe and effective in obese patients, but future randomized research is needed before incorporation into clinical practice can take place.
