NCT07158008 Comparison of Nissen-Sleeve and Gastric Bypass for GERD in Obese Patients
| NCT ID | NCT07158008 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jagiellonian University |
| Condition | Gastro Esophageal Reflux |
| Study Type | INTERVENTIONAL |
| Enrollment | 560 participants |
| Start Date | 2025-07-31 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 560 participants in total. It began in 2025-07-31 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07158008 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Gastro Esophageal Reflux. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07158008 currently recruiting?
Yes, NCT07158008 is actively recruiting participants. Contact the research team at piotr.malczak@uj.edu.pl for enrollment information.
Where is the NCT07158008 trial being conducted?
This trial is being conducted at Krakow, Poland.
Who is sponsoring the NCT07158008 clinical trial?
NCT07158008 is sponsored by Jagiellonian University. The trial plans to enroll 560 participants.