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 gastroesophageal reflux disease (GERD). N-SG is a modified sleeve gastrectomy procedure that incorporates an anti-reflux mechanism based on the Nissen fundoplication technique, while RYGB is a well-established bariatric procedure with proven anti-reflux efficacy.
Background and Rationale:
Severe obesity (BMI ≥ 40 or ≥ 35 with comorbidities) is a growing health problem and is frequently associated with GERD. While sleeve gastrectomy (SG) is currently the most widely performed bariatric procedure globally, it has been associated with the development or worsening of GERD in a significant number of cases. RYGB has become the standard surgical approach in obese patients with pre-existing GERD due to its high rate of reflux symptom resolution. However, RYGB involves more complex anatomical changes, carries a risk of nutritional deficiencies, and limits future endoscopic access to the biliary tract.
The Nissen-Sleeve Gastrectomy (N-SG), first described by David Nocca in 2016, combines SG with a 360-degree gastric fundoplication wrap (similar to that used in traditional Nissen fundoplication). This technique preserves gastrointestinal continuity and potentially maintains endoscopic access to the duodenum, while adding a reflux barrier. Early observational studies suggest favorable outcomes in terms of GERD resolution while retaining the benefits of SG. However, no large-scale randomized controlled trial has compared N-SG with RYGB in this specific patient population.
Study Design:
This is a prospective, single-center, randomized controlled non-inferiority trial conducted at the University Hospital in Kraków, Poland. Patients with obesity and clinically confirmed GERD will be randomized in a 1:1 ratio to receive either N-SG or RYGB. Randomization is performed using a computer-generated block randomization schedule. Allocation will be concealed in sealed envelopes and opened immediately prior to surgery. The estimated sample size for the randomized arms is 140 patients (70 per group), accounting for an assumed 15% dropout rate, and powered to detect non-inferiority with a margin of 10%.
In addition to the randomized comparison, a non-randomized observational control group of approximately 420 patients undergoing standard SG without GERD symptoms will be enrolled. This group will allow propensity-matched analyses and further comparisons of outcomes.
Surgical Techniques:
Nissen-Sleeve Gastrectomy (N-SG): The greater curvature of the stomach is mobilized, short gastric vessels are divided, and the fundus is used to create a posterior wrap around the distal esophagus. A 360-degree fundoplication (Nissen) is performed laparoscopically. This is followed by longitudinal gastric resection using a 40Fr bougie to calibrate the sleeve.
Roux-en-Y Gastric Bypass (RYGB): A small proximal gastric pouch is created. A 100 cm alimentary (Roux) limb is anastomosed to the pouch. A biliopancreatic limb of 150 cm is created via jejunojejunostomy, and the continuity of the gastrointestinal tract is restored. The stomach remnant and duodenum are excluded from the alimentary flow.
Follow-Up and Data Collection:
All patients will be followed for at least 12 months postoperatively. Clinical data will be collected at baseline, postoperatively, and at follow-up visits. Blood samples will be obtained at four time points: (1) day of surgery, (2) first postoperative day, (3) one week post-discharge (during suture removal), and (4) at 12-month follow-up. Blood will be analyzed for serum ghrelin levels using ELISA-based testing.
GERD symptoms will be assessed pre- and postoperatively using the validated GerdQ questionnaire. A score below 5 at 12 months, along with discontinuation of proton pump inhibitor (PPI) therapy for at least 60 days, will be considered remission of GERD.
Outcomes:
Primary outcome: GERD symptom resolution at 12 months post-op, comparing N-SG to RYGB.
Secondary outcomes: Weight loss (measured as %EWL, %TWL, and BMI change), serum ghrelin levels, incidence of postoperative complications (Clavien-Dindo scale), and quality of life metrics.
Control Group:
Patients without GERD undergoing standard SG will serve as an observational control cohort. This group will provide comparative data on weight loss and metabolic changes without the influence of pre-existing reflux disease. Their data will be used for secondary analyses and matched comparisons.
Ethical Considerations:
The study has received approval from the Bioethics Committee of Jagiellonian University Medical College. Written informed consent will be obtained from all participants. Participation is voluntary, and subjects may withdraw at any time. The N-SG technique is investigational in Poland and may only be offered within this trial framework. Patients declining randomization will receive the standard of care (RYGB or SG based on clinical indication).
Potential Risks and Complications:
Both RYGB and SG are well-established surgical procedures. N-SG may be associated with additional risks specific to fundoplication, such as cuff leak or stenosis. These complications will be managed with standard endoscopic or surgical protocols as needed. All participants will be closely monitored throughout the study.
This trial seeks to evaluate whether N-SG can offer equivalent reflux control to RYGB while avoiding the anatomical disruption and long-term risks associated with bypass surgery. The results may support broader adoption of N-SG as a tailored option for obese patients with GERD.
