OmentopexyNCT07854613
De Novo Gastroesophageal Reflux Disease After Sleeve Gastrectomy With and Without Omentopexy
A study testing Sleeve Gastrectomy With Omentopexy and Sleeve Gastrectomy Without Omentopexy in people with Omentopexy and Sleeve Gastrectomy, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Omentopexy, Sleeve Gastrectomy, Gastroesophageal Reflux Disease
- What is being tested?
- Sleeve Gastrectomy With Omentopexy and Sleeve Gastrectomy Without Omentopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2026to 1 Nov 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Yuntao Nie, MD, 18611835860, nytnyt1231@163.com
About this study
Official title: Comparative Effects of Sleeve Gastrectomy With and Without Omentopexy on Gastroesophageal Reflux Disease in Patients With Obesity
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?
Read more
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.
- Being tested
- Sleeve Gastrectomy With Omentopexy, Sleeve Gastrectomy Without Omentopexy
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve Gastrectomy With OmentopexyProcedure or 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 Without OmentopexyProcedure or surgery
Participants assigned to this intervention will undergo sleeve gastrectomy without omentopexy according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Sleeve Gastrectomy With Omentopexy | Experimental | Participants will undergo sleeve gastrectomy with omentopexy according to the study protocol. Receives: Procedure: Sleeve Gastrectomy With Omentopexy |
| Sleeve Gastrectomy Without Omentopexy | Active comparator | Participants will undergo sleeve gastrectomy without omentopexy according to the study protocol. Receives: Procedure: Sleeve Gastrectomy Without Omentopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of de novo postoperative gastroesophageal reflux disease (GERD)
The proportion of participants with a postoperative GERD-Q score of 8 or higher.
Measured: 12 months after surgery
Secondary outcomes (5)
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. The highest score was 75 and the lowest score was 0. Higher scores indicate greater severity of GERD symptoms.
Measured: 12 months after surgery
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.
Measured: 12 months after surgery
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.
Measured: 12 months after surgery
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).
Measured: 12 months after surgery
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.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OmentopexyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuntao Nie, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854613
- Sponsor's protocol ID
- CJBariatric008
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No