Carolina Restrepo

Early complications after cleft palate repair: a multivariate statistical analysis of 709 patients.

Abstract This study presents a large consecutive institutional experience with primary cleft palate repairs. The purpose of this study was to determine the incidence of early complications after cleft palate surgery in a series of nonsyndromic children treated at the authors’ comprehensive cleft center. This retrospective analysis includes 709 consecutive patients with cleft palate treated by 6 different staff surgeons at Guwahati Comprehensive Cleft Care Center between April 2011 and December 2012. Secondary cases were excluded from this study. The patients were initially followed up between 1 week and 1 month after surgery. The overall incidence of early complications was determined, and the effect of the extent of clefting, the type of repair, the age at repair, and the operating surgeon were analyzed. Early complications in this study include dehiscence of the wound, fistula formation, hanging palate, and total or partial flap necrosis. There was a 2.4% rate (17/709) of take-back to the operating room in the immediate postoperative period for control of bleeding, although no blood transfusions were required. The incidence of postoperative fistulas in this series was 3.9% (20/512). There was a statistically significant increase in the incidence of cleft palatal fistula for Veau IV clefts, but there were no significant differences with respect to operating surgeon, patient sex, patient age, and type of palatoplasty. The complication and fistula rate is consistent with other published reports from developed countries and provides evidence for the value of this model for surgical delivery in the developing world.

Scalable, Sustainable Cost-effective Surgical Care: A Model for Safety and Quality in the Developing World, Part Iii

Background The Guwahati Comprehensive Cleft Care Center (GCCCC) utilizes a high-volume, subspecialized institution to provide safe, quality, and comprehensive and cost-effective surgical care to a highly vulnerable patient population. Methods The GCCCC utilized a diagonal model of surgical care delivery, with vertical inputs of mission-based care transitioning to investments in infrastructure and human capital to create a sustainable, local care delivery system. Over the first 2.5 years of service (May 2011–November 2013), the GCCCC made significant advances in numerous areas. Progress was meticulously documented to evaluate performance and provide transparency to stakeholders including donors, government officials, medical oversight bodies, employees, and patients. Results During this time period, the GCCCC provided free operations to 7,034 patients, with improved safety, outcomes, and multidisciplinary services while dramatically decreasing costs and increasing investments in the local community. The center has become a regional referral cleft center, and governments of surrounding states have contracted the GCCCC to provide care for their citizens with cleft lip and cleft palate. Additional regional and global impact is anticipated through continued investments into education and training, comprehensive services, and research and outcomes. Conclusion The success of this public private partnership demonstrates the value of this model of surgical care in the developing world, and offers a blueprint for reproduction. The GCCCC experience has been consistent with previous studies demonstrating a positive volume-outcomes relationship, and provides evidence for the value of the specialty hospital model for surgical delivery in the developing world.

Improving patient follow-up in developing regions.

Background Cleft surgery follow-up in developing regions is challenging. This study evaluated rates, costs, and satisfaction of 2 follow-up programs at the Guwahati Comprehensive Cleft Care Centre (GC4) in Assam, India. Methods For this study, 10,582 postoperative visits were analyzed from May 2011 to November 2013. A questionnaire was administered to subsets of follow-up patients at both locations. Costs were calculated. Results Eighty-five percent of patients had follow-up at GC4, and 15% were seen in the patients’ local districts. One hundred ninety-five questionnaires were completed (122 at GC4, 73 in local districts). Patients with local follow-up had fewer accompanying family members (mean, 1.95 vs 0.99; P = 0.00), fewer days off work (mean, 1.84 vs 1.15; P = 0.19), less lost income (Indian rupees 367 vs 143, P = 0.00), and lower direct costs (mean Rs, 911 vs 299; P = 0.00). The financial burden of local follow-up was significantly lower (P = 0.003). No significant differences were seen for convenience, likelihood of attending follow-up, or satisfaction. Follow-ups increased after revising programs from a mean of 139 monthly visits (follow-up to surgery ratio of 0.722) to a mean of 363 visits (ratio of 1.57). The center’s mean cost for local follow-up was Rs 303 per patient, whereas the estimated costs would have been Rs 1100 for follow-up at the center. Conclusions This study demonstrates potential improvements in costs and outcomes by changing the model of care. Despite significant follow-up challenges, much progress can be achieved through process changes and outreach follow-up programs. The results have important applications across the developing world.

Scalable, sustainable cost-effective surgical care: a model for safety and quality in the developing world, part I: challenge and commitment.

Background With an estimated backlog of 4,000,000 patients worldwide, cleft lip and cleft palate remain a stark example of the global burden of surgical disease. The need for a new paradigm in global surgery has been increasingly recognized by governments, funding agencies, and professionals to exponentially expand care while emphasizing safety and quality. This three-part article examines the evolution of the Operation Smile Guwahati Comprehensive Cleft Care Center (GCCCC) as an innovative model for sustainable cleft care in the developing world. Methods The GCCCC is the result of a unique public-private partnership between government, charity, and private enterprise. In 2009, Operation Smile, the Government of Assam, the National Rural Health Mission, and the Tata Group joined together to work towards the common goal of creating a center of excellence in cleft care for the region. Results This partnership combined expertise in medical care and training, organizational structure and management, local health care infrastructure, and finance. A state-of-the-art surgical facility was constructed in Guwahati, Assam which includes a modern integrated operating suite with an open layout, advanced surgical equipment, sophisticated anesthesia and monitoring capabilities, central medical gases, and sterilization facilities. Conclusion The combination of established leaders and dreamers from different arenas combined to create a synergy of ambitions, resources, and compassion that became the backbone of success in Guwahati.

Scalable, sustainable cost-effective surgical care: a model for safety and quality in the developing world, part II: program development and quality care.

Background The Guwahati Comprehensive Cleft Care Center (GCCCC) is committed to free medical and surgical care to patients afflicted with facial deformities in Assam, India. A needs-based approach was utilized to assemble numerous teams, processes of care, and systems aimed at providing world-class care to the most needy of patients, and to assist them with breaking through the barriers that prohibit them from obtaining services. Methods A team of international professionals from various disciplines served in Guwahati full time to implement and oversee patient care and training of local counterparts. Recruitment of local professionals in all disciplines began early in the scheme of the program and led to gradual expansion of all medical teams. Emphasis was placed on achieving optimal outcome for each patient treated, as opposed to treating the maximum number of patients. Results The center is open year round to offer full-time services and follow-up care. Along with surgery, GCCCC provides speech therapy, child life counseling, dental care, otolaryngology, orthodontics, and nutrition services for the cleft patients under one roof. Local medical providers participated in a model of graded responsibility commiserate with individualized skill and progress, and gradually assumed all leadership positions and now account for 92% of the workforce. Institutional infrastructure improvements positioned and empowered teams of skilled local providers while implementing systemized perioperative processes. Conclusion This needs-based approach to program development in Guwahati was successful in optimization of quality and safety in all clinical divisions

Speech and Speech-Related Quality of Life After Late Palate Repair: A Patient's Perspective.

AbstractMany patients with cleft palate deformities worldwide receive treatment at a later age than is recommended for normal speech to develop. The outcomes after late palate repairs in terms of speech and quality of life (QOL) still remain largely unstudied. In the current study, questionnaires were used to assess the patients’ perception of speech and QOL before and after primary palate repair. All of the patients were operated at a cleft center in northeast India and had a cleft palate with a normal lip or with a cleft lip that had been previously repaired. A total of 134 patients (7–35 years) were interviewed preoperatively and 46 patients (7–32 years) were assessed in the postoperative survey. The survey showed that scores based on the speech handicap index, concerning speech and speech-related QOL, did not improve postoperatively. In fact, the questionnaires indicated that the speech became more unpredictable (P < 0.01) and that nasal regurgitation became worse (P < 0.01) for some patients after surgery. A total of 78% of the patients were still satisfied with the surgery and all of the patients reported that their self-confidence had improved after the operation. Thus, the majority of interviewed patients who underwent late primary palate repair were satisfied with the surgery. At the same time, speech and speech-related QOL did not improve according to the speech handicap index-based survey. Speech predictability may even become worse and nasal regurgitation may increase after late palate repair, according to these results.

Lessons Learned From Two Consecutive Cleft Lip and Palate Missions and the Impact of Patient Education.

Abstract Two consecutive cleft missions were conducted in Guwahati, northeastern India in December 2010 and January 2011. In the later mission, a standardized patient education program for postoperative care was introduced. The objective of this study was to retrospectively evaluate the impact of the patient education program on cleft lip complications in terms of wound infection and dehiscence. Two hundred ninety-eight cleft lip repairs were performed in the first mission and 220 (74%) returned for early follow-up. In the second mission, 356 patients were operated on and 252 (71%) returned for follow-up. From the first mission, 8 patients (3.7%) were diagnosed with lip wound infection and 21 patients (9.6%) with lip dehiscence. After the second mission, only 1 patient (0.4%) returned with a wound infection and 16 (6.4%) were diagnosed with dehiscence. Using binary logistic regression including age, cleft type, postoperative antibiotics, surgeon, and patient education program as covariates, the patient education program stood out as the only variable with a statistically significant impact on the incidence of postoperative wound infections. Even though the incidence of lip dehiscence was reduced by one third when the patient education program was utilized, our regression model singled out the surgeons as the only factor significantly related to this type of complication. Moreover, no benefits of postoperative antibiotic prophylaxis were found. Further analysis of the data also implied that the use of tissue adhesive as a compliment to sutures does not reduce the risk of dehiscence.

Limited Chances of Speech Improvement After Late Cleft Palate Repair.

AbstractLate primary palatal repair is a common phenomenon, and many patients across the world will be operated on at a far later age than is suggested for normal speech development. Nevertheless, little is known about the speech outcomes after these procedures and conflicting results exist among the few studies performed. In this study, blinded preoperative and postoperative speech recordings from 31 patients operated on at Guwahati Comprehensive Cleft Care Center in Assam, India, older than 7 years were evaluated. Six non-Indian speech and language pathologists evaluated hypernasal resonance and articulation, and 4 local laymen evaluated the speech intelligibility/acceptability of the samples.In 25 of 31 cases, the evaluators could not detect any speech improvement in the postoperative recordings. A clear trend of postoperative improvement was only found in 6 of the 31 patients. Among these 6 patients, lesser clefts were overrepresented. Our findings together with previous studies suggest that late palate repairs have the potential to improve speech, but the probability for improvement and degree of improvement is low, especially in older adolescents and adults with complete clefts.

Improved Early Cleft Lip and Palate Complications at a Surgery Specialty Center in the Developing World

Objective: To evaluate complication rates following cleft lip and cleft palate repairs during the transition from mission-based care to center-based care in a developing region. Patients and Design: We performed a retrospective review of 3419 patients who underwent cleft lip repair and 1728 patients who underwent cleft palate repair in Guwahati, India between December 2010 and February 2014. Of those who underwent cleft lip repair, 654 were treated during a surgical mission and 2765 were treated at a permanent center. Of those who underwent cleft palate repair, 236 were treated during a surgical mission and 1491 were treated at a permanent center. Setting: Two large surgical missions to Guwahati, India, and the Guwahati Comprehensive Cleft Care Center (GCCCC) in Assam, India. Main Outcome Measure: Overall complication rates following cleft lip and cleft palate repair. Results: Overall complication rates following cleft lip repair were 13.2% for the first mission, 6.7% for the second mission, and 4.0% at GCCCC. Overall complication rates following cleft palate repair were 28.0% for the first mission, 30.0% for the second mission, and 15.8% at GCCCC. Complication rates following cleft palate repair by the subset of surgeons permanently based at GCCCC (7.2%) were lower than visiting surgeons (P < .05). Conclusions: Our findings support the notion that transitioning from a mission-based model to a permanent facility-based model of cleft care delivery in the developing world can lead to decreased complication rates.

Primary Cleft Lip and Palate Repair in Assam, India: Does Preoperative Anthropometric Analysis Help Identify Patients With Increased Surgical Risk in a Clinically Prescreened Population?

Objective To compare anthropometric z-scores with incidence of post-operative complications for patients undergoing primary cleft lip or palate repair. Design This was a retrospective observational analysis of patients from a surgical center in Assam, India, and includes a cohort from a single surgical mission completed before the opening of the center. Setting Patients included in the study underwent surgery during an Operation Smile mission before the opening of Operation Smiles Guwahati Comprehensive Cleft Care Center in Guwahati, India. The remaining cohort received treatment at the center. All patients received preoperative assessment and screening; surgery; and postoperative care, education, and follow-up. Patients, Participants Our sample size included 1941 patients and consisted of all patients with complete information in the database who returned for follow-up after receiving primary cleft lip repair or primary cleft palate repair between January 2011 and April 2013. Interventions Preoperative anthropometric measurements. Main Outcome Measure(s) Postoperative complications. Results Anthropometric z-scores were not a significant predictor of adverse surgical outcomes in the group analyzed. Palate surgery had increased risk of complication versus lip repair, with an overall odds ratio of 5.66 (P < .001) for all patients aged 3 to 228 months. Conclusions Anthropometric z-scores were not correlated with increased risk of surgical complications, possibly because patients were well screened for malnutrition before surgery at this center. Primary palate repair is associated with an approximate fivefold increased risk of developing postoperative complication(s) compared with primary lip repair.