The SLEEVE-GERD Trial: A Comparative Study of Nissen-Sleeve and Roux-en-Y Gastric Bypass in Obese Patients With GERD

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Poland
Szpital Uniwersytecki w Krakowie
RECRUITING
Krakow
Contact Information
Primary
Piotr Małczak, PhD, MD
piotr.malczak@uj.edu.pl
0048124002600
Time Frame
Start Date: 2025-07-31
Estimated Completion Date: 2028-09
Participants
Target number of participants: 560
Treatments
Experimental: Nissen-Sleeve Gastrectomy (N-SG)
Participants in this arm will undergo laparoscopic sleeve gastrectomy combined with Nissen fundoplication. The procedure includes partial preservation of the gastric fundus to form a 360-degree wrap around the distal esophagus, followed by sleeve resection of the remaining stomach. This technique aims to provide both weight loss and reflux control while maintaining gastrointestinal continuity.
Active_comparator: Roux-en-Y Gastric Bypass (RYGB)
Participants in this arm will undergo standard laparoscopic Roux-en-Y gastric bypass. The procedure includes the creation of a small gastric pouch, a 100 cm alimentary (Roux) limb, and a 150 cm biliopancreatic limb. The bypass alters the gastrointestinal anatomy to promote weight loss and has established effectiveness in reducing GERD symptoms.
Other: Sleeve Gastrectomy - Control (No GERD)
This non-randomized observational group includes patients without GERD symptoms undergoing standard sleeve gastrectomy. Data from this group will be used for secondary matched analyses to evaluate weight loss and hormonal changes, serving as a control for comparative evaluation with the randomized arms.
Sponsors
Leads: Jagiellonian University

This content was sourced from clinicaltrials.gov