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Comparison of Nissen-Sleeve and Gastric Bypass for GERD in Obese Patients

RecruitingNAAges 18 Years - 65 YearsAllJagiellonian University
NCT07158008 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This randomized clinical trial aims to compare two surgical techniques for the treatment of obesity in patients who also have symptoms of gastroesophageal reflux disease (GERD). The study will compare Nissen-Sleeve Gastrectomy (N-SG)-a sleeve gastrectomy combined with a reflux-preventing procedure-to the Roux-en-Y Gastric Bypass (RYGB), which is the current standard surgical option for obese patients with GERD. Both procedures are widely used to treat severe obesity, but they differ in how they affect the digestive system and the potential for reflux control, nutritional outcomes, and future surgical options. N-SG is a newer technique that preserves the natural pathway of the gastrointestinal tract and allows standard endoscopic access to the bile ducts, which may be beneficial for long-term patient care. RYGB, on the other hand, bypasses part of the stomach and small intestine, which m

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📋 Eligibility rules (as published)
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
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What it tests

  • Nissen-Sleeve Gastrectomy (N-SG)
  • Roux-en-Y Gastric Bypass (RYGB)
  • Sleeve Gastrectomy (SG)
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Where

1 site
Szpital Uniwersytecki w Krakowie
Krakow, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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