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

NCT07854613 — Not applicable, Not yet recruiting, 140 participants, China-Japan Friendship Hospital

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Comparative Effects of Sleeve Gastrectomy With and Without Omentopexy on Gastroesophageal Reflux Disease in Patients With Obesity

RegistryNCT07854613
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, prevention
Enrollment140 (Estimated)
SponsorChina-Japan Friendship Hospital (Other)
ConditionsOmentopexy, Sleeve Gastrectomy, Gastroesophageal Reflux Disease
InterventionsSleeve Gastrectomy With Omentopexy, Sleeve Gastrectomy Without Omentopexy (Procedure)
Datesstart 2026-10-15 (estimated), primary completion 2027-10-15 (estimated), completion 2027-11-01 (estimated), first posted 2026-10-02, last updated 2026-10-15
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Omentopexy All trials for Sleeve Gastrectomy All trials of Sleeve Gastrectomy With Omentopexy All trials of Sleeve Gastrectomy Without Omentopexy

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Sleeve Gastrectomy With OmentopexyExperimentalProcedure: Sleeve Gastrectomy With OmentopexyParticipants will undergo sleeve gastrectomy with omentopexy according to the study protocol.
Sleeve Gastrectomy Without OmentopexyActive comparatorProcedure: Sleeve Gastrectomy Without OmentopexyParticipants will undergo sleeve gastrectomy without omentopexy according to the study protocol.
  • 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 Without Omentopexy (Procedure): Participants assigned to this intervention will undergo sleeve gastrectomy without omentopexy according to the study protocol.

+Outcome measures

Primary outcomes

  • Prevalence of de novo postoperative gastroesophageal reflux disease (GERD) [12 months after surgery]: The proportion of participants with a postoperative GERD-Q score of 8 or higher.

Secondary outcomes

  • GERD severity assessed by the GERD-HRQL score [12 months after surgery]: The severity of gastroesophageal reflux disease will be assessed using the GERD-Health Related Quality of Life (GERD-HRQL) questionnaire. The highest score was 75 and the lowest score was 0. Higher scores indicate greater severity of GERD symptoms.
  • Endoscopic findings of gastroesophageal reflux disease [12 months after surgery]: 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.
  • Incidence of hiatal hernia [12 months after surgery]: 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.
  • Severity of reflux esophagitis according to the Los Angeles classification [12 months after surgery]: The severity of reflux esophagitis will be assessed by postoperative upper gastrointestinal endoscopy using the Los Angeles classification (Grades A, B, C, and D).
  • Postoperative proton pump inhibitor use [12 months after surgery]: 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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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.

+Locations (1)

FacilityCityCountryStatus
China-Japan Friendship HospitalBeijing, Beijing MunicipalityChina