Determinants of early surgical outcomes and complications following primary cleft lip and palate repair in selected Hospitals in Kenya.

Abstract

BACKGROUND: Cleft lip and palate is the most common congenital craniofacial anomaly managed by plastic surgeons. Its surgery has revolutionised over the last half century. However, there is no consensus with respect to the protocol, timing and the ideal technique of cleft lip and palate repair among surgeons. The goal of cleft surgery is to repair the affected structures to restore functional impairments and facial aesthetics. The best approach to cleft management is through multidisciplinary team approach through dedicated cleft and craniofacial centres. Many developing countries, however, still lack cleft centres making patient follow-up erratic. In Kenya, several patients undergo cleft surgery each year. The complication rates and the determinants of complications and outcomes following surgical repair are not known in our setting. Cleft lip and palate repairs may result in complications such as surgical site infection, dehiscence and fistulas. Poor outcomes and complications contribute significantly to the burden of care in these patients, as there arises further need for secondary procedures. OBJECTIVE: To evaluate determinants of early surgical outcomes and complications following primary cleft lip and palate repair in selected Hospitals in Kenya. STUDY DESIGN: This was a descriptive cross sectional study MATERIALS AND METHODS: The study was carried out from November 2019 to June 2020 at hospitals where cleft surgeries were carried out, that is, Kenyatta National Hospital (KNH), Moi Teaching and Referral Hospital (MTRH), Kenyatta University Teaching, Referral and Research Hospital (KUTRRH), Meru level 5 Hospital, Kapenguria level 5 Hospital, Kitale level 5 Hospital, Machakos level 5 Hospital. Consenting patients above 18 years, assenting minors and consenting parents/guardians with patients requiring primary cleft lip or palate surgery were recruited into the study. Ethics approval was obtained for this study. Permission was sought from the participating study sites. One hundred and forty-one (141) consecutive consenting participants meeting the inclusion criteria were included in this study and assessed at 4 weeks post operatively to determine the surgical outcomes and complications of repair. Patient’s demographics, pre-operative status that is., Haemoglobin, weight, type of cleft, presence of other congenital anomalies and intra-operative data on method of repair was collected using a researcher administered questionnaire. Photos were taken pre-operatively and post-operatively, analysed and scored using the PLAN score by 3 senior plastic surgeons to assess the cleft lip repair outcomes. The outcome of Cleft palate repairs was determined based on the integrity of repair that is, on the presence or absence of fistula. A good palate repair was defined as one without a fistula. Data collected were put into SPSS version 23 from where percentages and frequencies were derived. Cross tabulations between the outcomes (presence of fistula), patient factors (haemoglobin, weight, type of cleft, presence of other congenital anomalies and intra-operative data) was then done. Mann Whitney and Kruskal Wallis tests were run to assess for statistical significant differences. Spearman correlation test was run between different variables and presence of fistula among the palatal cohort, and different variables and scores for the lip cohort. To assess for reliability of the scores among the different raters on for the PLAN scores, coherence among raters was determined using Cohen’s kappa inter-rater reliability analysis. P-value of ≤ 0.05 was considered significant at 95% CI. Data were presented in tables and photographs. RESULTS: Left cleft lip and palate deformity was the most common pattern of presentation. The male to female ratio was 1:1.2. The ethnic groups from the central region of Kenya were the largest population in this study. Seventy nine percent (79%) of the patients had sporadic clefts with only 30% reporting a family history of clefts. Most patients had primary palate repair at 1-3years (mean 18 months) of age while the majority of cleft lip patients were below one year (mean 5.4months) at primary repair. Bardach’s two flap palatoplasty was the most common method of repair for Cleft palate. A relatively high rate of palate fistula formation of 37% was noted. Lower fistula rates occurred where vomer flaps were used to augment the nasal mucosal layer. Millard rotation and advancement or its modifications, was commonly used for cleft lip repair. The most common complication of cleft lip repair was hypertrophic scarring in 20% of the patients. In this study, there was no difference in outcome between use of Dermabond and sutures in cleft lip repair. Seventy percent (70%) of the patients were said to have good outcomes based on the PLAN score that showed significant inter-rater reliability. CONCLUSION: This study demonstrated a low complication rate and high patient satisfaction following cleft lip and palate surgery in Kenya. Intra-operative complications occurred more with palate repair and these increased the risk of ICU admission and prolonged hospital stay. The most significant factors determining cleft surgery outcome were the surgical technique and cleft severity. Surgeons with extensive experience in cleft surgery had good outcomes even with wide cleft lips in the absence of pre-surgical orthodontics.