[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657721":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":24,"interventions":35,"overallOfficials":13,"centralContacts":43,"locations":13,"responsibleParty":49,"collaborators":13,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":13,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":13,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":75,"whyStopped":13,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":81,"leadSponsor":83,"locationsCount":13},{"fullName":5,"class":6},"Fayoum University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"fistula formation","assessment the fistula formation after cleft palate repair by determination the site of fistula and time at which appear","6 months postoperative",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"TRIPLE",[21,22,23],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[25,30],{"label":26,"type":27,"description":13,"interventionNames":28},"furlow with buccinator","EXPERIMENTAL",[29],"Procedure: furlow with buccinator",{"label":31,"type":32,"description":13,"interventionNames":33},"two flap palatoplasty","ACTIVE_COMPARATOR",[34],"Procedure: two flap palatoplasty",[36,40],{"type":37,"name":26,"description":38,"armGroupLabels":39,"otherNames":13},"PROCEDURE","clefted patients were treated with furlow with buccinator flap",[26],{"type":37,"name":31,"description":41,"armGroupLabels":42,"otherNames":13},"clefted patients were treated with two flap palatoplasty",[31],[44],{"name":45,"role":46,"phone":47,"phoneExt":13,"email":48},"Shaimaa Refahee","CONTACT","01227407987","smr11@fayoum.edu.eg",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Shaimaa Mohsen","associate professor","100657721","furlow-with-buccinator-and-fistula-formation-100657721",false,"NCT07840911","Furlow With Buccinator and Fistula Formation","• Fistula Formation in Patients With Cleft Palate Following Primary Furlow Palatoplasty With Buccal Myomucosal Flap Versus Two Flap Palatoplasty","Inclusion Criteria:\n\n* 9-12 months old childreen with complete cleft lip and palate, nonsyndromic.\n* lip and palate repair performed by one craniofacial surgeon\n\nExclusion Criteria:\n\n* Patients with syndromic cleft lip.\n* Redu cases\n* Bilateral cleft lip\n* Associated Cardiac anomalies.\n* Any systemic condition","ALL","9 Months","12 Months",{"count":64,"type":65},20,"ESTIMATED","INTERVENTIONAL",[68],"NA","Furlow with buccal myomucosal flap (group 1) Local anesthesia with a vasoconstrictor will be injected at the beginning of the surgery after Z- flap outline marking. On the left side, myomucosal posteriorly based flap will be incised containing the levator palateni muscle with a 60◦ angle and elevated. Another small anteriorly-based nasal mucosa flap will be created. On the opposite side, oral mucosal anteriorly based flap with a 90◦ angle will be incised and elevated. Palatal muscle will be stripped and posteriorly based myomucosal flap was created containing palatal muscle and nasal mucosa. Nasal mucosa will be sutured followed by oral mucosa with minimal palatal muscle overlapping. The oral mucosa defect will be filled with BMMF Two flap palatoplasty surgical steps (group 2) A bilateral tongue like palatal flaps will be incised and elevated from the incisive foramen anteriorly to the hamulus posteriorly medial to the teeth and extended around the cleft area. Palatal muscles will be detached from the palatal shelves and separating it from the nsal mucosa. Nasal layer will be the firstly closed, followed by the muscle and oral mucosal layers. In case of the presence of a bare area of bone, it will be left to heal by secondary intention",[71],"Cleft Palate",[73,74],"cleft palate","fistula","NOT_YET_RECRUITING","2026-09-19",{"date":78,"type":79},"2026-09-25","ACTUAL",{"date":78,"type":65},{"date":82,"type":65},"2027-09-30",{"name":5,"class":6}]