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

ConditionsOmentopexySleeve GastrectomyGastroesophageal Reflux Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChina-Japan Friendship Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sleeve Gastrectomy With Omentopexy

    Procedure/Surgery

    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

    Procedure/Surgery

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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Sleeve Gastrectomy With OmentopexyExperimental treatment 1 intervention
Group B: Sleeve GastrectomyActive comparator 1 intervention

Trial outcomes

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.

Time frame
12 months after surgery

Secondary outcomes

1

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.

Time frame
12 months after surgery
2

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.

Time frame
12 months after surgery
3

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.

Time frame
12 months after surgery
4

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).

Time frame
12 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China-Japan Friendship Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: