Comparison of Nissen-Sleeve and Gastric Bypass for GERD in Obese Patients

NCT07158008 | Recruiting

• 1 other identifier: SLEEVE-GERD Trial
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro Esophageal Reflux; Severe Obesity; Bariatric Surgery

Keywords

Nissen-Sleeve; Gastric Bypass; GERD

Outcome Measures

Primary Outcomes (1)

• GERD Symptom Remission

  Resolution of GERD symptoms, defined as: No need for proton pump inhibitors (PPIs) for at least 60 consecutive days, and GerdQ questionnaire score \< 7 at 12-month follow-up. Comparison between Nissen-Sleeve Gastrectomy (N-SG) and Roux-en-Y Gastric Bypass (RYGB) arms.

  12 months post-surgery

Secondary Outcomes (7)

• Percent Excess Weight Loss (%EWL)

  12 months post-surgery

• Percent Total Weight Loss (%TWL)

  12 months post-surgery

• Change in Body Mass Index (BMI)

  Difference in BMI from baseline to 12 months. Compared across all three study arms.

• Change in Serum Ghrelin Levels

  Baseline (day of surgery), postoperative day 1, day 7 after discharge, and 12 months post-surgery

• Postoperative Complication Rate (Clavien-Dindo Classification ≥ Grade III)

  Up to 30 days post-surgery

Study Arms (3)

Nissen-Sleeve Gastrectomy (N-SG)

EXPERIMENTAL

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.

Procedure: Nissen-Sleeve Gastrectomy (N-SG)

Roux-en-Y Gastric Bypass (RYGB)

ACTIVE COMPARATOR

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.

Procedure: Roux-en-Y Gastric Bypass (RYGB)

Sleeve Gastrectomy - Control (No GERD)

OTHER

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.

Procedure: Sleeve Gastrectomy (SG)

Interventions

Nissen-Sleeve Gastrectomy (N-SG) PROCEDURE

Laparoscopic Nissen-Sleeve Gastrectomy is a modification of standard sleeve gastrectomy that incorporates an anti-reflux procedure. The greater curvature of the stomach is mobilized and short gastric vessels are divided. A segment of the gastric fundus is preserved and passed behind the distal esophagus to create a 360-degree wrap (Nissen fundoplication) around the lower esophageal sphincter. The crura of the diaphragm are approximated if necessary. Following fundoplication, the remainder of the stomach is resected longitudinally over a 40 French bougie using a linear stapling device, creating a tubular gastric conduit. This approach aims to achieve weight loss while providing a functional anti-reflux barrier and maintaining gastrointestinal continuity.

Nissen-Sleeve Gastrectomy (N-SG)

Roux-en-Y Gastric Bypass (RYGB) PROCEDURE

Laparoscopic Roux-en-Y Gastric Bypass is a standard bariatric procedure that combines gastric restriction with intestinal bypass. A small proximal gastric pouch is created using linear staplers, completely separating it from the gastric remnant. A 100 cm alimentary (Roux) limb of jejunum is measured from the ligament of Treitz and anastomosed to the gastric pouch (gastrojejunostomy) using a linear stapler. A jejunojejunostomy is then performed 150 cm distal to the gastrojejunostomy to connect the biliopancreatic limb to the alimentary limb, restoring intestinal continuity. The mesenteric defects are closed to reduce the risk of internal hernia. This procedure promotes weight loss and has established effectiveness in reducing gastroesophageal reflux symptoms.

Roux-en-Y Gastric Bypass (RYGB)

Sleeve Gastrectomy (SG) PROCEDURE

Laparoscopic Sleeve Gastrectomy is a restrictive bariatric procedure involving longitudinal resection of the stomach to create a tubular gastric conduit. The greater curvature is mobilized and short gastric vessels are divided. Using a bougie as a guide, the stomach is divided with a linear stapling device from the antrum to the angle of His, removing approximately 75-80% of gastric volume, including most of the fundus. This reduces stomach capacity and ghrelin production, promoting weight loss while maintaining gastrointestinal continuity.

Sleeve Gastrectomy - Control (No GERD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux; Obesity, Morbid

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Central Study Contacts

Piotr Małczak, PhD, MD

CONTACT

0048124002600; piotr.malczak@uj.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Due to the nature of the surgical interventions, masking of participants and healthcare providers is not feasible. Both the patients and the surgical team are aware of the assigned intervention. Outcome assessors and data analysts will be blinded during statistical analysis to minimize potential bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Surgery Department

Model Details: Participants with obesity and gastroesophageal reflux disease (GERD) symptoms are randomly assigned in a 1:1 ratio to undergo either Nissen-Sleeve Gastrectomy (N-SG) or Roux-en-Y Gastric Bypass (RYGB). Randomization is stratified and block-based, with allocation concealed using sealed envelopes. A third, non-randomized observational cohort of patients without GERD undergoing standard sleeve gastrectomy (SG) is included to allow matched secondary analyses. The primary comparison is between the two randomized arms (N-SG vs. RYGB).

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)