← Back to all trials
Not Yet Recruiting
NCT07854613
De Novo Gastroesophageal Reflux Disease After Sleeve Gastrectomy With and Without Omentopexy
Conditions: Omentopexy, Sleeve Gastrectomy, Gastroesophageal Reflux Disease
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: China-Japan Friendship Hospital
Location: China-Japan Friendship Hospital Beijing Beijing Municipality
Summary
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:
Does 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?
Researchers will compare sleeve gastrectomy with omentopexy to sleeve gastrectomy without omentopexy to determine whether omentopexy reduces the incidence of postoperative GERD.
Participants will:
Undergo sleeve gastrectomy with or without omentopexy according to their randomized treatment assignment.
Complete the GERD-Q questionnaire after surgery to assess gastroesophageal reflux symptoms.
Attend postoperative follow-up visits for assessment of GERD and other clinical outcomes.
Eligibility Criteria
Inclusion Criteria:
1. Adults aged 18 to 65 years.
2. Body mass index (BMI) ≥32.5 kg/m².
3. Participants who meet the clinical indications for sleeve gastrectomy for the treatment of obesity.
4. Participants who are willing to undergo sleeve gastrectomy and comply with the study protocol and postoperative follow-up schedule.
Exclusion Criteria:
1. Preoperative gastroesophageal reflux disease (GERD), defined by any of the following:
1. GERD-Q score ≥8;
2. Regular use of high-dose proton pump inhibitors (PPIs) for the management of reflux symptoms;
3. Patient-reported typical symptoms of gastroesophageal reflux, including heartburn or acid regurgitation.
2. Hiatal hernia identified by preoperative upper gastrointestinal endoscopy.
3. Reflux esophagitis classified as Los Angeles grade B, C or D on preoperative upper gastrointestinal endoscopy.
4. Barrett's esophagus.
5. Previous bariatric surgery.
Source: ClinicalTrials.gov (NCT07854613). StuddyBuddy aggregates publicly available trial information.