Status:
RECRUITING
Comparison of Nissen-Sleeve and Gastric Bypass for GERD in Obese Patients
Lead Sponsor:
Jagiellonian University
Conditions:
Gastro Esophageal Reflux
Severe Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Detailed Description
This randomized clinical trial is designed to compare the safety and effectiveness of Nissen-Sleeve Gastrectomy (N-SG) versus Roux-en-Y Gastric Bypass (RYGB) in patients with obesity and symptoms of g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT07158008
Start Date
July 31 2025
End Date
September 1 2028
Last Update
September 5 2025
Active Locations (1)
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1
Szpital Uniwersytecki w Krakowie
Krakow, Poland, 30-688