Actively Recruiting
The SLEEVE-GERD Trial: Comparing Nissen-Sleeve Gastrectomy and Roux-en-Y Gastric Bypass for Obese Patients with GERD
Led by Jagiellonian University · Updated on 2025-09-05
560
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating two surgical methods for treating obesity in patients who also experience symptoms of gastroesophageal reflux disease (GERD). This study compares the newer Nissen-Sleeve Gastrectomy (N-SG), which combines sleeve gastrectomy with an anti-reflux procedure, to the standard Roux-en-Y Gastric Bypass (RYGB). The goal is to determine if N-SG is not worse than RYGB in reducing GERD symptoms one year after surgery, while also examining weight loss, quality of life, surgical complications, and hormone changes related to appetite. Participants will be randomly assigned to receive either N-SG, which preserves the gastrointestinal tract's natural pathway and includes a 360-degree wrap around the esophagus, or RYGB, which reroutes parts of the stomach and small intestine to help reduce reflux and promote weight loss. Additionally, a separate group of patients without GERD will undergo standard sleeve gastrectomy to serve as a control for comparison. All surgical procedures are laparoscopic and follow specific technical steps as described. During the year-long follow-up, participants will have blood samples collected at surgery, the day after, one week after discharge, and at 12 months to measure serum ghrelin levels. GERD symptoms will be assessed with a validated questionnaire before and after surgery, alongside weight loss and quality of life evaluations. The study also monitors surgical complications and the need for proton pump inhibitor therapy. This comprehensive data collection aims to improve bariatric treatment personalized for patients with obesity and reflux.
CONDITIONS
Brief Title
Comparison of Nissen-Sleeve and Gastric Bypass for GERD in Obese Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Provided written informed consent
- Eligible for bariatric surgery based on national guidelines (BMI ≥ 40 kg/m² or BMI ≥ 35 kg/m² with related health issues)
- Presence of symptomatic gastroesophageal reflux disease defined by regular use of proton pump inhibitors, GerdQ score above 6, or endoscopic evidence of esophagitis (grade B or higher)
- For control group: no GERD symptoms or history
You will not qualify if you...
- History of prior anti-reflux surgery
- History of upper gastrointestinal tract surgery
- Active smoking or history of nicotine use
- Severe heart failure (NYHA Class III or IV)
- Pregnancy or planned pregnancy during the study
- Any condition interfering with study participation or increasing risk as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo one of the surgical procedures: Nissen-Sleeve Gastrectomy (N-SG), Roux-en-Y Gastric Bypass (RYGB), or Sleeve Gastrectomy (SG) depending on their assigned group.
1 surgery visit (in-person)
Duration - Up to 7 days post-surgery
Participants receive immediate post-operative monitoring and care including hospitalization and early recovery assessments.
Daily visits during hospital stay and 1 visit for suture removal about 1 week after discharge
Duration - 12 months
Participants are followed up to assess recovery, weight loss, GERD symptoms, serum ghrelin levels, and quality of life over 12 months after surgery.
Approximately 6 visits including blood draws at surgery day, postoperative day 1, 1 week after discharge, and at 12 months
Trial Site Locations
Total: 1 location
1
Szpital Uniwersytecki w Krakowie
Krakow, Poland, 30-688
Actively Recruiting
Research Team
P
Piotr Małczak, PhD, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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