Nissen‑Sleeve versus Roux‑en‑Y gastric bypass for reflux in people with severe obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Szpital Uniwersytecki w Krakowie
  Krakow, Poland Recruiting

Study contacts

• Study coordinator: Piotr Małczak, PhD, MD
• Email: piotr.malczak@uj.edu.pl
• Phone: 0048124002600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.