De Novo Gastroesophageal Reflux Disease After Sleeve Gastrectomy With and Without Omentopexy

NCT07854613 | Not Yet Recruiting

• 1 other identifier: CJBariatric008
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Omentopexy; Sleeve Gastrectomy; Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• GERD severity assessed by the GERD-HRQL score

  12 months after surgery

• Endoscopic findings of gastroesophageal reflux disease

  12 months after surgery

• Incidence of hiatal hernia

  12 months after surgery

• Severity of reflux esophagitis according to the Los Angeles classification

  12 months after surgery

• Postoperative proton pump inhibitor use

  12 months after surgery

Study Arms (2)

Sleeve Gastrectomy With Omentopexy

EXPERIMENTAL

Participants will undergo sleeve gastrectomy with omentopexy according to the study protocol.

Procedure: Sleeve Gastrectomy With Omentopexy

Sleeve Gastrectomy

ACTIVE COMPARATOR

Participants will undergo sleeve gastrectomy without omentopexy according to the study protocol.

Procedure: Sleeve Gastrectomy

Interventions

Sleeve Gastrectomy With Omentopexy 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.

Sleeve Gastrectomy With Omentopexy

Sleeve Gastrectomy PROCEDURE

Participants assigned to this intervention will undergo sleeve gastrectomy without omentopexy according to the study protocol.

Sleeve Gastrectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 65 years.
• Body mass index (BMI) ≥32.5 kg/m².
• Participants who meet the clinical indications for sleeve gastrectomy for the treatment of obesity.
• Participants who are willing to undergo sleeve gastrectomy and comply with the study protocol and postoperative follow-up schedule.

You may not qualify if:

• Preoperative gastroesophageal reflux disease (GERD), defined by any of the following:
• GERD-Q score ≥8;
• Regular use of high-dose proton pump inhibitors (PPIs) for the management of reflux symptoms;
• Patient-reported typical symptoms of gastroesophageal reflux, including heartburn or acid regurgitation.
• Hiatal hernia identified by preoperative upper gastrointestinal endoscopy.
• Reflux esophagitis classified as Los Angeles grade B, C or D on preoperative upper gastrointestinal endoscopy.
• Barrett's esophagus.
• Previous bariatric surgery.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Yuntao Nie, MD

CONTACT

18611835860; nytnyt1231@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

CN (1)