Reducing reflux after sleeve gastrectomy using gastropexy
A Clinical Intervention Study Exploring Gastropexy as a Measure to Reduce Gastro-oesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy
This study is testing if a procedure called gastropexy can help reduce reflux symptoms in very overweight patients who are having sleeve gastrectomy surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 550 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Helse Forde Academic / other |
| Locations | 4 sites (Førde and 3 other locations) |
| Trial ID | NCT05704348 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of gastropexy in reducing gastroesophageal reflux symptoms in morbidly obese patients undergoing sleeve gastrectomy. Participants will be randomly assigned to receive either gastropexy or no gastropexy during their surgery. The study will assess both subjective reflux symptoms and objective evidence of reflux over a follow-up period of five years. By suturing the gastric remnant to the gastrocolic ligament, the researchers hypothesize that they can prevent the migration of the stomach and thus reduce reflux incidence.
Who should consider this trial
Good fit: Ideal candidates for this study are morbidly obese patients scheduled for sleeve gastrectomy.
Not a fit: Patients under 18 years old or those with a history of previous antireflux surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients by reducing reflux symptoms after bariatric surgery.
How similar studies have performed: While gastropexy is a novel approach in this context, similar studies have shown promise in reducing reflux symptoms after other types of bariatric surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients planned for bariatric surgery with primary LSG Exclusion Criteria: * Age below 18 yrs * Use of ARM for other reasons than reflux * Previous antireflux surgery * Inability to comprehend and respon to patient related outcome (PRO) questionnaire
Where this trial is running
Førde and 3 other locations
- Helse Forde — Førde, Norway (Not_yet_recruiting)
- Aleris Oslo — Oslo, Norway (Recruiting)
- Volda sjukehus — Volda, Norway (Recruiting)
- Voss sjukehus — Voss, Norway (Recruiting)
Study contacts
- Study coordinator: Villy Vage, MD PhD
- Email: villy.vage@helse-bergen.no
- Phone: 47 90863744
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.