**4. Operative and perioperative protocols**

In-depth analyses of outcomes from cases completed during the first few years of operation at GCCCC helped establish standardized protocols for the peri-operative and operative care of cleft patients, which is more widely applicable in India and other LMICs. The cumulative effect of these protocols has been to decrease rates of early complications following cleft lip and palate repair as reported in our comparison of mission-based and center-based care. Protocols are supported by a retrospective analysis of outcomes from a consecutive cohort of patients. Our group analyzed rates of early surgical complications from 2062 patients who presented for early follow up after primary cleft lip repair at GCCCC between 2011 and 2013 [27]. All patients received a single pre-operative dose of intravenous cefuroxime, and all patients and families underwent an educational program for post-operative care. Surgical technique was also standardized for the majority of cases (Mohler rotationadvancement technique for unilateral cleft lip and Millard-Mulliken technique for bilateral cleft lip). Malnourished patients were enrolled in a nutrition program and were not operated on until they were considered fit for surgery. Overall, 4.4% of patients developed an early complication (wound dehiscence and/or infection), which represents a three-fold improvement from OS's initial mission to Guwahati. Logistic regression revealed that dehiscence was significantly associated with visiting surgeons (surgeons who were at GCCCC for less than 6 months) (OR 2.64; 95% CI 1.61 to 4.33; p < 0.001), complete clefts (OR 1.83; 95% CI 1.07 to 3.11; p < 0.05), and bilateral clefts (OR 2.01; 95% CI 1.14 to 3.57; p > 0.05) (**Figure 4**). Our results indicate that center-based care and standardized perioperative protocols can improve outcomes in LMIC settings.

A separate analysis of 1408 patients who presented for early follow up after primary cleft palate repair during the same period revealed an early complication rate of 16.9% with a fistula rate of 13.6% [28]. Logistic regression identified cleft type (Veau classification) (OR 1.52; 95% CI 1.27 to 1.81; p < 0.001), visiting status of surgeon (OR 1.60; 95% CI 1.15 to 2.21; p < 0.01), and increasing patient age (OR 1.03; 95% CI 1.01 to 1.05; p < 0.01) as significant contributors to the development of complications (**Table 2**). The results of these analyses collectively indicate that complex cases should only be performed by providers with extensive experience in treating the types of pathology seen in LMICs.

A subsequent study evaluated a subset of 512 patients who underwent cleft palate repair by 6 permanent staff surgeons at GCCCC [29]. The combined fistula rate was 3.9%. Multivariate analysis revealed that Veau IV cleft palates had significantly higher rates of early post-operative complications, but more importantly, that there were no differences in complication rates among the 6 surgeons. The staff surgeons at GCCCC were trained to follow the same foundational principles of cleft palate repair. These includes adequate tissue mobilization for tension-free repair, delicate tissue handling, and multi-layered palatal closure. The outcome of this study validates the training received by the staff surgeons and emphasizes the importance of standardization even in surgeon education.

An additional benefit of center-based care is that it provides the infrastructure necessary for controlled research. Our group performed a prospective, double-blinded, randomized, placebo-controlled study at GCCCC to evaluate the efficacy of extended post-operative antibiotics following cleft palate repair in LMICs [30]. Five hundred eighteen patients were randomized into two cohorts, one receiving 5 days of oral amoxicillin and the other receiving only one pre-operative dose of intravenous cefuroxime. The incidence of early complications was reduced in the treatment group (8.7% vs. 13.8%), highlighting again the importance of tailoring care to the specific communities

**41**

**Figure 4.**

*\**

**Table 2.**

*and (B) cleft type.*

areas all around the world.

*Visiting versus long-term (>6 months of service at the center).*

*Optimizing Outcomes in Cleft Surgery*

*DOI: http://dx.doi.org/10.5772/intechopen.89882*

involved. While patients undergoing cleft palate repair in developed regions uniformly receive only one pre-operative dose of antibiotics, the results of this study show that patients in resource-poor settings with limited access to hygiene benefit from extended antibiotic coverage. This is evidence that rigorous evaluation of outcomes from specific

*Logistic regression analysis of factors related to postoperative complications after primary palate repair.*

*Incidence of wound dehiscence after primary lip repair according to (A) surgeon status (visiting or permanent)* 

**Covariate OR (95% CI) p** Cleft Type 1.516 (1.269–1.811) <0.001 Age 1.028 (1.010–1.045) <0.01 Surgeon\* 1.599 (1.154–2.214) <0.01

Based on the data collected from these studies, OS has produced a set of evidencebased recommendations for improving outcomes in cleft surgery (**Table 3**). These principles continue to direct OS's efforts to improve outcomes in resource-limited

populations helps shape best practices and ultimately improves outcomes.
