[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658634":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":29,"studyPopulation":29,"armGroups":40,"interventions":53,"overallOfficials":29,"centralContacts":61,"locations":67,"responsibleParty":82,"collaborators":29,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":29,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":29,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":29,"overallStatus":106,"whyStopped":29,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"China-Japan Friendship Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Prevalence of de novo postoperative gastroesophageal reflux disease (GERD)","The proportion of participants with a postoperative GERD-Q score of 8 or higher.","12 months after surgery",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"GERD severity assessed by the GERD-HRQL score","The severity of gastroesophageal reflux disease will be assessed using the GERD-Health Related Quality of Life (GERD-HRQL) questionnaire. Higher scores indicate greater severity of GERD symptoms.",{"measure":18,"description":19,"timeFrame":12},"Endoscopic findings of gastroesophageal reflux disease","Postoperative upper gastrointestinal endoscopy will be performed to assess endoscopic evidence of gastroesophageal reflux disease, including reflux esophagitis and other relevant findings. The presence or absence of endoscopic evidence of gastroesophageal reflux disease will be recorded.",{"measure":21,"description":22,"timeFrame":12},"Incidence of hiatal hernia","The presence of hiatal hernia will be assessed by postoperative upper gastrointestinal endoscopy. The presence and size of hiatal hernia will be recorded based on postoperative upper gastrointestinal endoscopy.",{"measure":24,"description":25,"timeFrame":12},"Severity of reflux esophagitis according to the Los Angeles classification","The severity of reflux esophagitis will be assessed by postoperative upper gastrointestinal endoscopy using the Los Angeles classification (Grades A, B, C, and D).",{"measure":27,"description":28,"timeFrame":12},"Postoperative proton pump inhibitor use","The use of proton pump inhibitors (PPIs) for the management of postoperative GERD will be recorded, including the type of PPI, dosage, frequency of administration, and treatment duration.",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":35,"maskingDescription":29,"whoMasked":36},"TRIPLE",[37,38,39],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"Sleeve Gastrectomy With Omentopexy","EXPERIMENTAL","Participants will undergo sleeve gastrectomy with omentopexy according to the study protocol.",[46],"Procedure: Sleeve Gastrectomy With Omentopexy",{"label":48,"type":49,"description":50,"interventionNames":51},"Sleeve Gastrectomy","ACTIVE_COMPARATOR","Participants will undergo sleeve gastrectomy without omentopexy according to the study protocol.",[52],"Procedure: Sleeve Gastrectomy",[54,58],{"type":55,"name":42,"description":56,"armGroupLabels":57,"otherNames":29},"PROCEDURE","Participants assigned to this intervention will undergo sleeve gastrectomy with omentopexy according to the study protocol. Omentopexy will be performed by fixation of the gastric sleeve to the adjacent omental tissue following sleeve gastrectomy.",[42],{"type":55,"name":48,"description":59,"armGroupLabels":60,"otherNames":29},"Participants assigned to this intervention will undergo sleeve gastrectomy without omentopexy according to the study protocol.",[48],[62],{"name":63,"role":64,"phone":65,"phoneExt":29,"email":66},"Yuntao Nie, MD","CONTACT","18611835860","nytnyt1231@163.com",[68],{"facility":5,"status":29,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Beijing","Beijing Municipality","100029","China","CN",{"type":75,"coordinates":76},"Point",[77,78],116.39723,39.9075,{"lat":78,"lon":77},[81],{"name":63,"role":64,"phone":65,"phoneExt":29,"email":66},{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Yuntao Nie","Principal Investigator","100658634","de-novo-gastroesophageal-reflux-disease-after-sleeve-gastrectomy-with-and-without-omentopexy-100658634",false,"NCT07854613","De Novo Gastroesophageal Reflux Disease After Sleeve Gastrectomy With and Without Omentopexy","Comparative Effects of Sleeve Gastrectomy With and Without Omentopexy on Gastroesophageal Reflux Disease in Patients With Obesity","Inclusion Criteria:\n\n1. Adults aged 18 to 65 years.\n2. Body mass index (BMI) ≥32.5 kg\u002Fm².\n3. Participants who meet the clinical indications for sleeve gastrectomy for the treatment of obesity.\n4. Participants who are willing to undergo sleeve gastrectomy and comply with the study protocol and postoperative follow-up schedule.\n\nExclusion Criteria:\n\n1. Preoperative gastroesophageal reflux disease (GERD), defined by any of the following:\n\n   1. GERD-Q score ≥8;\n   2. Regular use of high-dose proton pump inhibitors (PPIs) for the management of reflux symptoms;\n   3. Patient-reported typical symptoms of gastroesophageal reflux, including heartburn or acid regurgitation.\n2. Hiatal hernia identified by preoperative upper gastrointestinal endoscopy.\n3. Reflux esophagitis classified as Los Angeles grade B, C or D on preoperative upper gastrointestinal endoscopy.\n4. Barrett's esophagus.\n5. Previous bariatric surgery.","ALL","18 Years","65 Years",{"count":97,"type":98},140,"ESTIMATED","INTERVENTIONAL",[101],"NA","The goal of this clinical trial is to compare the effects of sleeve gastrectomy with and without omentopexy on gastroesophageal reflux disease (GERD) in patients with obesity. The main question it aims to answer is:\n\nDoes the addition of omentopexy to sleeve gastrectomy reduce the incidence of postoperative GERD compared with sleeve gastrectomy alone, as measured by the proportion of participants with a postoperative GERD-Q score ≥8?\n\nResearchers will compare sleeve gastrectomy with omentopexy to sleeve gastrectomy without omentopexy to determine whether omentopexy reduces the incidence of postoperative GERD.\n\nParticipants will:\n\nUndergo sleeve gastrectomy with or without omentopexy according to their randomized treatment assignment.\n\nComplete the GERD-Q questionnaire after surgery to assess gastroesophageal reflux symptoms.\n\nAttend postoperative follow-up visits for assessment of GERD and other clinical outcomes.",[104,48,105],"Omentopexy","Gastroesophageal Reflux Disease","NOT_YET_RECRUITING","2026-09-27",{"date":109,"type":110},"2026-10-02","ACTUAL",{"date":112,"type":98},"2026-10-15",{"date":114,"type":98},"2027-11-01",{"name":5,"class":6},1]