A Randomized Controlled Trial Evaluating Patients With Lax Gastroesophageal Junction to Initial Sleeve Gastrectomy With or Without Concomitant Crural Repair (REPAIR)

What this Trial Is About

Researchers are studying patients with obesity who have a lax gastroesophageal junction, specifically those with a Hill's grade III gastroesophageal flap valve, to investigate the effects of adding hiatal hernia repair to laparoscopic sleeve gastrectomy (LSG). This trial aims to see if repairing the hiatal hernia during LSG can reduce postoperative erosive esophagitis (EE), a common complication after LSG. The study addresses an important question because current recommendations often avoid LSG in patients with reflux or EE, and the trial may help expand options for suitable patients. Participants will be randomized into two groups: one receiving standard LSG alone and the other receiving LSG combined with a hiatal hernia repair. Both procedures use a standardized surgical technique with a 40Fr bougie and a 5-port approach. Postoperative care includes a liquid diet with vitamins for two weeks followed by solid foods. In the hiatal hernia repair group, a cruroplasty is performed during surgery. The trial is double-blinded and conducted at two centers. Throughout the one-year study period, participants will undergo evaluations including endoscopy to check for erosive esophagitis, quality of life questionnaires, and assessments of gastroesophageal reflux and dysphagia symptoms at several time points. The main outcome is the presence or severity of EE at one year post-surgery. Secondary outcomes include quality of life and reflux-related symptoms. Participants will be closely monitored for any complications or changes in health during the follow-up.

Crural Repair During Laparoscopic Sleeve Gastrectomy in Patients With a Lax Gastroesophageal Junction