Study protocol: gastroesopahgeal reflux disease after N-sleeve versus Roux-en-Y gastric bypass (GINSBY): a randomised controlled trial.

Background: Laparoscopic sleeve gastrectomy (LSG) and Laparoscopic Roux-en-Y gastric bypass (LRYGB) are the most frequently performed procedures in bariatric surgery. Morbidly obese patients with gastroesophageal reflux disease (GERD) are only eligible for LRYGB. For patients with a contraindication for LRYGB or a specific wish for LSG, there is a new procedure the Nissen-Sleeve (N-Sleeve). The aim of this study is to compare GERD improvement at one year after N-Sleeve versus LRYGB.
Method: This is a single centre, phase III, parallel-group randomised controlled non-inferiority trial. Morbidly obese patients older than 18 with GERD according to the Montreal definition are included after obtaining informed consent. Exclusion criteria: achalasia, abnormalities on gastroscopy, super obese (BMI ≥ 50kg/m2), Crohn’s disease and medical history of great abdominal surgery. Patients are randomised between N-Sleeve and LRYGB. The primary outcome is recovery of GERD, defined as < 8 points on the gastroesophageal reflux disease questionnaire (GERD-Q). Secondary outcome measures are quality of life, weight loss, PPI use, postoperative complications, effect on comorbidities, presence of grade of oesophagitis (grade A-D) and/ or Barrett’s oesophagus, and cost-effectiveness. Follow-up is after 1, 2, 3, 4, and 5 years. After one year al patients undergo a gastroscopy and at every follow-up moment questionnaires are filled in: GERD-Q, RAND-36, BAROS, EQ-5D, iMCQ, and iPCQ.
Ethics and dissemination: The protocol has been approved by the Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 15 September 2021. The trial results will be submitted for publication in a peer-reviewed journal and at conference presentations.

The N-sleeve is no worse at curing GERD compared to a LRYGB

baseline 1 year, 2 years, 3 years 4 years, 5 years

N-Sleeve or Roux-en-Y gastric bypass