Repairing the esophagus during weight loss surgery for patients with a weak valve
A Randomized Controlled Trial Evaluating PAtients With Lax Gastroesophageal Junction to Initial Sleeve Gastrectomy With or Without Concomitant Crural Repair (REPAIR)
This study tests if fixing a hiatal hernia during weight loss surgery can help people with a weak valve have fewer problems like acid reflux and esophagus damage after their surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | Sengkang General Hospital Academic / other |
| Locations | 2 sites (Singapore and 1 other locations) |
| Trial ID | NCT05330910 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of repairing a hiatal hernia during laparoscopic sleeve gastrectomy (LSG) on the incidence of postoperative gastroesophageal reflux disease (GERD) and erosive esophagitis (EE). The study aims to determine if patients with a lax gastroesophageal junction and hiatal hernia experience fewer complications after surgery when the hernia is repaired simultaneously. Participants will be divided into two groups: one receiving LSG alone and the other receiving LSG with hiatal hernia repair. The trial seeks to provide insights into the best surgical approach for patients at risk of postoperative complications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-65 with a Hill's grade III gastroesophageal junction who are planning to undergo laparoscopic sleeve gastrectomy.
Not a fit: Patients with documented erosive esophagitis or those with Hill's grade I, II, or IV gastroesophageal junction will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the risk of postoperative GERD and EE in patients undergoing bariatric surgery.
How similar studies have performed: Previous studies have shown mixed results regarding the benefits of hiatal hernia repair during LSG, indicating that this approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 21-65 years old * Able to provide informed consent * Hill's grade III gastroesophageal junction on preoperative endoscopy * Opted to undergo laparoscopic sleeve gastrectomy as their bariatric procedure Exclusion Criteria: * Unable or unwilling to provide informed consent * Contraindications to laparoscopic sleeve gastrectomy * Opted not to undergo laparoscopic sleeve gastrectomy * Had previous upper gastrointestinal surgery * Had documented erosive esophagitis on preoperative endoscopy * Had Hill's grade I, II or IV gastroesophageal junction on preoperative endoscopy
Where this trial is running
Singapore and 1 other locations
- Singapore General Hospital — Singapore, Singapore (Recruiting)
- Sengkang General Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Baldwin Po Man Yeung, MBChB, FRCS — Sengkang General Hospital
- Study coordinator: Koy Min Chue, MBBS, FRCSEd
- Email: chuekoymin@gmail.com
- Phone: +65 91196091
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.