Trends of cleft surgeries and predictors of late primary surgery among children with cleft lip and palate at the University College Hospital, Nigeria: a retrospective cohort study

Abstract

Background: Cleft of the lip and palate is the most common craniofacial birth defect with a worldwide incidence of one in 700 live births. Early surgical repairs are aimed at improving appearance, speech, hearing, psychosocial development and avoiding impediments to social integration. Many interventions including the Smile Train partner model have been introduced to identify and perform prompt surgical procedures for the affected babies. However, little is known about the trends of the incidence and surgical procedures performed at our hospital and the relationship between the clinical characteristics of the patients and the timing of primary repairs. Objective To determine the trends in cleft surgeries, patterns of cleft surgeries and identify factors related to late primary repair at the University College Hospital, UCH, Ibadan, Nigeria. Methods A retrospective cohort study and trends analysis of babies managed for cleft lip and palate from January 2007 to January 2019 at the UCH, Ibadan was conducted. The demographic and clinical characteristics were extracted from the Smile Train enabled cleft database of the hospital. The annual trends in rate of cleft surgeries (number of cleft surgeries per 100,000 live births) was represented graphically. Chi square test and Student’s t-test were utilised to assess the association between categorical and continuous variables and delay in cleft surgery (≥12 months for lip repair, ≥18months for palatal repair).  Kaplan-Meier graphs with log-rank test was used to examine the association between sociodemographic variables and the outcome (late surgery). Univariable and multivariable Cox proportional hazard regression was conducted to obtain the hazard or predictors of delayed cleft lip surgery. Stata version 17 (Statacorp, USA) statistical software was utilised for analysis Results There were 314 cleft surgeries performed over the thirteen-year period of study. The male to female ratio was 1.2:1. The mean age of the patients was 58.08 ± 99.65 months. The median age and weight of the patients were 11 (IQR:5-65) months and 8 (IQR: 5.5-16) kg respectively. Over half (n=184, 58.6 %) of the cleft surgeries were for primary repairs of the lip and a third (n=94, 29.9%) were surgeries for primary repairs of the palate. Millard’s rotation advancement flap was the commonest lip repair technique with Fishers repair introduced within two years into the end of the study. Bardachs two flap palatoplasty has replaced Von Lagenbeck palatoplasty as the commonest method of palatal repair. The prevalence of late primary cleft lip repair was about a third of the patients having primary cleft lip surgery while the prevalence of late palatal repair was more than two thirds of those who received primary palatoplasty. Compared with children who had bilateral cleft lip, children with unilateral cleft lip had a significantly increased risk of late primary repair (Adj HR: 22.4, 955 CI: 2.59 - 193.70, P-value = 0.005).     Conclusion There has been a change from Von Lagenbeck palatoplasty to Bardachs two-flap palatoplasty. Intra-velar veloplasty and Fisher’s method of lip repair were introduced in later years. There was a higher risk of late primary repair in children with unilateral cleft lip.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

The author(s) received no specific funding for this work.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was approved by the University of Ibadan/University College Hospital institutional review board. (Ethics review number: NHREC/05/01/2008a)

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

The data underlying the results presented in the study are available from Smile Train Express

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