xRead - Treatment of Cleft Lip and Cleft Palate (May 2025)

2

The Cleft Palate Craniofacial Journal 0(0)

described by Heister in 1727 as the Glandula molaris (molar gland). 9,11 Bichat, in 1802, described it as a “ ball ” of adipose tissue between the buccinator, the masseter, and the skin. For this reason, it is also known as the Boule de Bichat. 12 Hudson et al reported in 1995 on four cases of the use of BFP in the closure of secondary palatal or dentoalveolar cleft defects. 13 Zhao et al fi rst utilized BFP in primary cleft palate repair to cover the raw surface of the lateral relaxing incisions and/or fi ll the dead space between oral and nasal layers in the hard-soft palate junction. 14 Since then, BFP use in cleft surgery has notably expanded. Its access, availability, rich blood supply, and lack of a second ary surgical site 2,4,15 have popularized its use among many cleft surgeons, with increasing reports in the literature for both primary and secondary palatoplasties. Theoretical advan tages of BFP in cleft surgery include diminished tension and decreased fi stula formation, scar contracture, and associated maxillary constriction. 2,4,15 At this time, evidence for the use of BFP has not been systematically reviewed. The objectives of this systematic review are to identify the role of the BFP in primary and secondary cleft palate repair and the short and long-term clinical outcomes of its use. Methods This study is a systematic review of previously published studies and does not involve any primary data collection from human participants; therefore, institutional review board approval and subjects ’ consent were not required. The authors conducted a systematic search with no publication date restrictions in three databases (Pubmed/Medline, Embase and Web of Science) in September 2022 according to the search query described in Supplemental File 1. Keywords “ cleft palate ” , “ palatoplasty ” , “ palate repair ” , “ buccal fat pad ” were included. Historic keywords such as “ Bichat fat pad ” were included to minimize reporting bias. The inclusion criteria were studies involving human subjects, use of BFP in primary or secondary cleft palate repair, sample with fi ve or more subjects in each of the groups, and written in the English language. Publications included were randomized trials, cohort, case-control, comparative studies, and case series. Exclusion criteria were BFP used for diagnoses other than cleft palate, animal or cadaveric studies, and litera ture review publications. After the completion of the database search, we excluded duplicate entries then reviewed titles and abstracts. After a scoping review of these, we identi fi ed the outcomes to be eval uated. We delimitated our primary outcomes as immediate postoperative complications, postoperative fi stula, and maxil lary growth. Secondary outcomes were time to mucosalization of the donor site, palatal length, speech and donor site morbid ity. Pertinent articles were retrieved in full-text and reviewed to determine if they ful fi lled the inclusion criteria. The following data were retrieved: Title, authors, date of publication, country, study design, number of patients, indication for palatoplasty, palatoplasty technique, function of BFP, clinical outcomes,

and time of follow-up. Database search, title and abstract review, and full manuscript review were completed by two authors (C.R.N. and L.O.L.). Con fl icts in data collection or article selection were resolved by a third author (R.E.K.). After data collection, the data were synthesized in charts for comparison purposes. The level of evidence of each study was evaluated using the criteria of the Oxford Centre for Evidence-Based Medicine. 16 The risk of bias of each non-randomized study was analyzed independently by two authors (C.R.N. and L.O.L.) using MINORS assessment tool, which evaluates eight domains in non-comparative studies and twelve domains in comparative studies. 17 A complete list of the domains evaluated is provided in Supplemental File 2. For this study, we consider low risk of bias if they ful fi ll all the domains requirements (except the “ Prospective collection of data ” in the MINORS tool to include retrospective studies), high risk of bias if they failed in reported adequately 2 or more domains, and moderate risk of bias the rest of them. In the case of randomized trials, the Cochrane risk of bias v.2.0 (RoB2) tool was employed. 18 This tool includes evaluation of bias in the following domains: randomization process, deviations from intended interventions, missing outcome data, measurement of the outcome and selection of the reported result. For this study, we consider a global low risk of bias if all the domains are scored as “ Low risk ” , high risk of bias if one or more domains are scored as “ High risk ” or two or more domains are score as “ Some concerns ” , and moderate risk of bias in all other cases. Consensus was reached between the two reviewers (C.R.N. and L.O.L.). Disagreements were resolved by the third author (R.E.K.). In case of suf fi cient homogeneity between studies, a quantitative analysis using Cochrane Review Manager tool (RevMan 5.4) was be performed. If not, we proceeded with a descriptive qualitative analysis. Results The search retrieved 152 reports, and 61 duplicate records were removed. Titles and abstracts for 91 records were screened, and 67 were excluded. Full-text review was performed for 24 reports. We also retrieved three additional reports from citation searching. Two reports were excluded because they did not meet the inclusion criteria. It was identi fi ed that two reports 19,20 discussed the same cohort, and data was collected from the more updated report. 19 Two other reports 4,21 were a poster presentation and the published manuscript of the same study, and data was collected from the manuscript. 4 Ultimately, 25 reports from 23 studies were included in the review. A PRISMA fl owchart is presented in Figure 1. 22 We reviewed 13 case series, 9 related to primary palato plasty, 2 to secondary palatoplasty and 2 that addressed both. One study that addressed both primary and secondary palato plasty had limited subjects in the secondary palatoplasty group, so this subgroup was not evaluated. One case series 23 described the authors ’ usual surgical technique for palate repair, not focused speci fi cally on BFP, but as it was a large