Nissen‑Sleeve versus Roux‑en‑Y gastric bypass for reflux in people with severe obesity
The SLEEVE-GERD Trial: A Comparative Study of Nissen-Sleeve and Roux-en-Y Gastric Bypass in Obese Patients With GERD
This trial tests whether Nissen‑Sleeve gastrectomy or Roux‑en‑Y gastric bypass better controls GERD symptoms in adults who are eligible for bariatric surgery due to severe obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 560 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Jagiellonian University Academic / other |
| Locations | 1 site (Krakow) |
| Trial ID | NCT07158008 on ClinicalTrials.gov |
What this trial studies
This randomized trial will directly compare Nissen‑Sleeve gastrectomy (a sleeve gastrectomy combined with a 360° fundoplication wrap) to Roux‑en‑Y gastric bypass (RYGB) in adults with obesity and symptomatic GERD, with an observational sleeve gastrectomy group for patients without GERD. Participants meeting bariatric criteria and GERD definitions will be randomized to N‑SG or RYGB and followed for safety, reflux control, nutritional outcomes, and need for further procedures. The trial highlights differences in anatomical alteration, endoscopic access to the biliary tree, and potential long‑term nutritional risks between the two approaches. Outcomes will inform whether the newer N‑SG technique can match RYGB’s reflux control while preserving gastrointestinal continuity.
Who should consider this trial
Good fit: Adults (≥18 years) eligible for bariatric surgery (BMI ≥40 or ≥35 with comorbidities) who have symptomatic GERD defined by regular PPI use, a GerdQ >6, or endoscopic esophagitis, and who have not had prior upper GI or anti‑reflux surgery and are non‑smokers.
Not a fit: Patients without GERD, those with prior upper gastrointestinal or anti‑reflux surgery, active smokers, or those not eligible for bariatric surgery are unlikely to benefit from enrollment in the randomized comparison.
Why it matters
Potential benefit: If successful, the Nissen‑Sleeve approach could offer similar reflux control to RYGB while preserving normal GI continuity and reducing long‑term nutritional issues and limitations on endoscopic access.
How similar studies have performed: Roux‑en‑Y gastric bypass is an established, effective anti‑reflux bariatric operation, while Nissen‑Sleeve is a newer hybrid technique with encouraging early observational reports but limited randomized data to date.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: For N-Sleeve Gastrectomy (N-SG) and Roux-en-Y Gastric Bypass (RYGB) arms: * Age ≥ 18 years * Written informed consent provided * Eligible for bariatric surgery according to national guidelines (BMI ≥ 40 kg/m² or BMI ≥ 35 kg/m² with obesity-related comorbidities) * Presence of symptomatic gastroesophageal reflux disease (GERD), defined by at least one of the following: * Regular use of proton pump inhibitors (PPIs) * GerdQ score \> 6 * Endoscopic evidence of esophagitis (Los Angeles classification grade B or higher) For Sleeve Gastrectomy (SG) observational control group: * Age ≥ 18 years * Written informed consent provided * Eligible for bariatric surgery according to national guidelines (BMI ≥ 40 kg/m² or BMI ≥ 35 kg/m² with obesity-related comorbidities) * No symptoms or history of GERD Exclusion Criteria: * History of prior anti-reflux surgery * History of upper gastrointestinal tract surgery * Active smoking or history of nicotine use * Severe cardiac insufficiency (New York Heart Association Class III or IV) * Pregnancy or planned pregnancy during the study period (if applicable based on future additions) * Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with the study protocol or would pose additional risk
Where this trial is running
Krakow
- Szpital Uniwersytecki w Krakowie — Krakow, Poland (Recruiting)
Study contacts
- Study coordinator: Piotr Małczak, PhD, MD
- Email: piotr.malczak@uj.edu.pl
- Phone: 0048124002600
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.