NCT07158008Recruiting
Comparison of Nissen-Sleeve and Gastric Bypass for GERD in Obese Patients
The SLEEVE-GERD Trial: A Comparative Study of Nissen-Sleeve and Roux-en-Y Gastric Bypass in Obese Patients With GERD
Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 may lead to better reflux resolution but carries risks of nutritional deficiencies and altered anatomy. Eligible participants with obesity and GERD symptoms will be randomly assigned to receive either N-SG or RYGB. The primary goal is to evaluate whether N-SG is not inferior to RYGB in reducing GERD symptoms one year after surgery. Secondary outcomes include weight loss, quality of life, surgical complications, and changes in the hormone ghrelin, which is involved in appetite regulation. In addition, a larger control group of patients without GERD undergoing standard sleeve gastrectomy will be recruited to allow further comparisons. All participants will be followed for one year after surgery, with blood samples, questionnaires, and clinical data collected to assess both metabolic and reflux-related outcomes. This study is being conducted at the University Hospital in Kraków, Poland, and aims to improve the personalization of bariatric treatment for patients suffering from both obesity and reflux.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 560 (estimated)
- First submitted
- 28 Aug 2025
- Start date
- 31 Jul 2025
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Jagiellonian University
- Diseases
- Obesity
- NCT number
- NCT07158008
What you commit to
- Study type: Interventional
- Planned participants: 560
- From 31 Jul 2025 to the primary completion date, 31 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior anti-reflux surgery
Other illness
- History of upper gastrointestinal tract surgery
- Active smoking or history of nicotine use
- Severe cardiac insufficiency (New York Heart Association Class III or IV)
- 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
Other
- Pregnancy or planned pregnancy during the study period (if applicable based on future additions)
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Szpital Uniwersytecki w Krakowie Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.