Reducing reflux after sleeve gastrectomy using gastropexy
Official title: A Clinical Intervention Study Exploring Gastropexy as a Measure to Reduce Gastro-oesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy
Run by Helse Forde · NCT05704348 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 550 (estimated) |
| Sponsor | Helse Forde Academic / other |
| Locations | 4 sites (Førde and 3 other locations) |
| Status | Recruiting |
| Started | September 4, 2023 |
| Main results expected | December 2027 |
| Study ends | December 2030 |
| Registry record updated | October 30, 2024 |
| Trial ID | NCT05704348 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are morbidly obese patients scheduled for sleeve gastrectomy.
✕Probably not a fit
Patients under 18 years old or those with a history of previous antireflux surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While gastropexy is a novel approach in this context, similar studies have shown promise in reducing reflux symptoms after other types of bariatric surgery.
Who can join: the full rules
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 it's running
-
Aleris Oslo
Oslo, Norway Recruiting -
Volda sjukehus
Volda, Norway Recruiting -
Voss sjukehus
Voss, Norway Recruiting -
Helse Forde
Førde, Norway Not yet recruiting
Study contacts
- Study coordinator: Villy Vage, MD PhD
- Email: villy.vage@helse-bergen.no
- Phone: 47 90863744
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.