Influence of Severity on Aesthetic Outcomes of Unilateral Cleft Lip Repair in 1,823 Patients.

BACKGROUND: Although efforts to improve access to care for patients with cleft lip in the developing world have grown tremendously, there is a dearth of data regarding aesthetic outcomes after cleft lip repairs in this setting. Defining severity-outcome relationships has the potential to improve efficiency of care delivery in resource-limited settings, and to improve overall results. In this study, we investigate the relationship between initial cleft lip severity and early aesthetic outcomes following surgical repair of primary unilateral cleft lip. METHODS: Using previously validated tools to assess unilateral cleft lip severity and aesthetic outcome after repair, we evaluated 1,823 consecutive patients who underwent primary unilateral cleft lip/nose (UCL/N) repair. Three separate evaluators scored each case for a total of 5,469 total independent evaluations. RESULTS: Our results show that with increasing severity of UCL/N deformity, there is a corresponding decrease in early aesthetic outcome scores. Using our results, we established normative early aesthetic outcomes following repair for each severity grade of UCL/N deformity. CONCLUSIONS: In conclusion, this study has achieved a standardized, timely, and cost-effective evaluation of 1,823 surgical cases of primary UCL/N repair. This data set provides a normal distribution of aesthetic results according to initial cleft severity and defines a standard of "expected" aesthetic results after primary UCL/N repair. Our results also show a clear correlation between initial severity and immediate aesthetic result after surgery, though we also show that excellent results are possible regardless of initial cleft severity.

Validation of a Unilateral Cleft Lip Surgical Outcomes Evaluation Scale for Surgeons and Laypersons.

BACKGROUND: A standardized evaluation tool is needed for the assessment of surgical outcomes in cleft lip surgery. Current scales for evaluating unilateral cleft lip/nose (UCL/N) aesthetic outcomes are limited in their reliability, ease of use, and application. The Unilateral Cleft Lip Surgical Outcomes Evaluation (UCL SOE) scale measures symmetry of 4 components and sums these for a total score. The purpose of this study was to validate the SOE as a reliable tool for use by both surgeons and laypersons. METHODS: Twenty participants (9 surgeons and 12 laypeople) used the SOE to evaluate 25 sets of randomly selected presurgical and postsurgical standardized photographs of UCL/N patients. Interrater reliability for surgeon and laypeople was determined using an intraclass correlation coefficient (ICC). RESULTS: Individual surgeons and laypeople both reached an ICC in the "fair to good" range (ICC = 0.42 and 0.59, respectively). Averaging 2 evaluators in the surgeon group improved the ICC to 0.58 and in the laypeople group to 0.74, respectively. Averaging 3 evaluators increased the ICC for surgeons to the "good" range (ICC = 0.71) and the ICC for laypeople to the "very good" range (ICC = 0.82). CONCLUSIONS: Surgeon and layperson raters can reliably use the SOE to assess the aesthetics results after surgical repair of UCL/N, and improved reliability and reproducibility is achieved by averaging the scores of multiple reviewers.

Validation of the Unilateral Cleft Lip Severity Index for Surgeons and Laypersons.

BACKGROUND: Severity of the primary unilateral cleft lip/nose deformity (UCL/N) is postulated to play a key role in postoperative complications, aesthetic result, and need for secondary surgery. There is no validated and widely accepted classification scheme of initial cleft severity. The purpose of this study was to validate the Unilateral Cleft Lip Cleft Severity Index as a reliable tool for evaluating presurgical UCL/N deformity by both surgeons and laypersons. METHODS: Twenty-five participants (10 surgeons and 15 laypeople) evaluated 25 sets of randomly selected presurgical standardized photographs of UCL/N patients. Each participant rated patients on a scale of 1-4 using the Cleft Severity Index. Interrater reliability for surgeons, laypersons, and all participants was determined using an intraclass correlation coefficient. Histograms and regression analysis were performed to compare average ratings between groups. RESULTS: Interrater reliability for all groups was classified as "very good" determined by intraclass correlation coefficients of 0.837 (laymen), 0.885 (surgeons), and 0.848 (all participants). These results indicate that there was a high degree of interrater across all 3 groups and that both surgeons and laypersons can reliability rate cleft severity using the Cleft Severity Index. CONCLUSIONS: This study validates the use of the Cleft Severity Index by both surgeons and laypersons as a reliable tool for evaluating the degree of presurgical severity of patients with UCL/N. The Unilateral Cleft Lip Cleft Severity Index can thus serve as a reproducible and reliable grading system for primary UCL/N deformity and to categorize patients for future outcomes studies.

Surgical Complications in 1408 Primary Cleft Palate Repairs Operated at a Single Center in Guwahati, Assam, India.

OBJECTIVE: To analyze surgical complications after primary cleft palate repair in a setting with limited resources. PATIENTS AND DESIGN: A total of 1608 consecutive cleft palate repairs with 1408 follow-ups, operated upon between 2011 and 2013, were reviewed retrospectively through medical records. Patients were 10 months to 50 years old at the time of surgery, with a median age of 9 years. SETTING: Guwahati Comprehensive Cleft Care Center, Guwahati, India. INTERVENTION: Primary cleft palate repair. MAIN OUTCOME MEASURES: Postoperative complications in terms of necrosis, dehiscence, fistula, infection, and "hanging palate" were assessed, as was perioperative bleeding. Logistic regression was used with complication (yes/no) as the binary dependent variable and with age, cleft type, and surgeon (visiting/long-term) as covariates. RESULTS: The overall incidence of postoperative complications was 16.9% with a fistula rate of 13.6%. The incidence of perioperative bleeding was 1.8%. Logistic regression analysis identified cleft severity (P ≤ .001) and visiting surgeon (P ≤ .01) as factors related to the incidence of postoperative complications. Age at surgery was related to both the incidence of postoperative complications (P ≤ .001) and perioperative bleeding (P < .05). CONCLUSION: Due to increased risks of surgical complications, older patients with complete clefts should only be operated upon after careful consideration. In addition, these patients should be assigned to surgeons experienced with this cleft type.

Role of Postoperative Antimicrobials in Cleft Palate Surgery: Prospective, Double-Blind, Randomized, Placebo-Controlled Clinical Study in India.

BACKGROUND: The purpose of this study was to determine whether administration of postoperative antibiotics affects the incidence of complications after primary cleft palate repair in a developing area. METHODS: This study was a prospective, double-blind, randomized, placebo-controlled trial composed of 518 consecutive patients who underwent primary cleft palate repair at a single institution. Patients were aged 1 to 43 years at the time of surgery (median, 9 years). The patients were divided randomly into two groups. One group received a 5-day regimen of oral amoxicillin (50 mg/kg/day) postoperatively and the other group received placebo medication. Both groups received a single dose of cefuroxime (30 mg/kg) before incision. Patients and providers were blinded to the randomization. Patients were followed postoperatively for early complications (infection and wound breakdown) and for late complications (palatal fistulas). RESULTS: The incidence of early complications was 13.8 percent among the patients in the placebo group and 8.7 percent among the patients in the antibiotic group (p = 0.175). Fistulas were noted in 17.1 percent in the placebo group and in 10.7 percent in the antibiotic group (p = 0.085). Logistic regression analysis identified visiting surgeons as the only covariate related to early complications (OR, 3.71; p < 0.001). However, the use of placebo (OR, 2.09; p = 0.037), female sex (OR, 2.04; p = 0.047), and Veau III and IV (OR, 3.31; p = 0.004) were observed as factors associated with the incidence of fistulas. CONCLUSION: The authors' results indicate that postoperative antibiotic prophylaxis can reduce the incidence of fistulas after primary cleft palate repair in a developing area.

Limited Chances of Speech Improvement After Late Cleft Palate Repair.

Late 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.

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

Many 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.

The efficacy of vomer flap for closure of hard palate during primary lip repair.

BACKGROUND AND AIM: This study presents the institutional experience of the use of vomer flap for early closure of hard palate during unilateral complete cleft-lip repair. The purpose of this study was to determine the survival rate of the vomer flap and to investigate its effect on the subsequent palatoplasty. PATIENTS AND METHODS: This retrospective analysis includes 101 non-syndromic patients with complete unilateral cleft lip who received a vomer flap for the closure of the hard palate during cleft-lip repair. Patients were aged 6 months to 28 years (median 1 year). Success rates of the vomer flaps were assessed clinically and through pre-operative photographs taken at the time of subsequent palate repair. Ninety-two patients returned for second-stage palate repair, and 74 patients with adequate post-operative follow-up information were statistically analysed. RESULTS: Of the 101 patients who were operated with primary lip repair and simultaneous vomer flap, only 54 (52.4%) vomer flaps healed completely. Out of 92 patients who returned for subsequent palatoplasty, 71 (77.2%) were operated with the two-flap technique, and 19 (20.7%) received von Langenbeck repairs. Seven (9.1%) patients had a surgical complication. The failure of previous vomer repair and von Langenbeck surgical technique were identified as factors associated with post-operative complications. CONCLUSIONS: We conclude that failed vomer flaps increased the risks of complications in the subsequent palate repair. Furthermore, efforts to use von Langenbeck technique rather than the two-flap technique also resulted in increased surgical complications. As a result, we have abandoned the use of the vomer flap with primary lip repair.

Early Surgical Complications After Primary Cleft Lip Repair: A Report of 3108 Consecutive Cases.

OBJECTIVE: To analyze short term surgical complications after primary cleft lip repair. PATIENTS AND DESIGN: A total of 3108 consecutive lip repairs with 2062 follow-ups were reviewed retrospectively through medical records. Patients were aged 3 months to 75 years at the time of surgery, with a median of 7 years. SETTING: Guwahati Comprehensive Cleft Care Center, Assam, India. INTERVENTION: Primary cleft lip repair. MAIN OUTCOME MEASURES: Documented complications in terms of dehiscence, necrosis, infection, and suture granuloma were compiled. Logistic regression was used with dehiscence (yes/no) or infection (yes/no) as binary dependant variables. Age, cleft type, and surgeon (visiting/long term) were used as covariates. RESULTS: Among the 2062 patients who returned for early follow-up, 90 (4.4%) had one or more complications. Dehiscence (3.2%) and infection (1.1%) were the most common types of complication. Visiting surgeon, complete cleft, and bilateral cleft were significantly associated with wound dehiscence, and complete cleft was associated with wound infection according to the logistic regression analysis. Of patients with bilateral complete clefts, 6.9% suffered from some degree of wound dehiscence. CONCLUSION: In a setting where presurgical molding is unavailable and patients present at all ages, lip wound dehiscence is a relatively common complication in patients with bilateral complete clefts. The risk of dehiscence, however, is reduced when these cases are assigned to surgeons with experience with these types of clefts. We also found that the incidence of wound infection can be kept relatively low, even without the use of postoperative antibiotics.

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.

Lessons learned from two consecutive cleft lip and palate missions and the impact of patient education.

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.