Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07158008

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionGastro Esophageal Reflux, Severe Obesity, Bariatric Surgery

Full registry 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

Treatments and study arms

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.

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.

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.

Primary outcomes

GERD Symptom Remission12 months post-surgery

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Szpital Uniwersytecki w Krakowie🇵🇱 Krakow, Poland

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Piotr Małczak, PhD, MDContact

Email · Call 0048124002600