Study to Test Gastropexy to Reduce Acid Reflux After Sleeve Gastrectomy Surgery in Obese Patients

What this Trial Is About

This trial investigates gastropexy as a method to reduce gastroesophageal reflux disease GERD symptoms in adults who are morbidly obese and scheduled for laparoscopic sleeve gastrectomy LSG. The study compares two groups to determine whether gastropexy decreases reflux symptoms and objective signs of reflux. LSG is widely used as a bariatric surgery, but it may increase GERD by allowing the stomach remnant to migrate upward into the chest, which this study aims to prevent by using gastropexy. Participants are randomly assigned to receive either sleeve gastrectomy with gastropexy, where the stomach remnant is sutured to the gastrocolic ligament, or sleeve gastrectomy without gastropexy. The study plans to enroll 550 patients. Follow-up visits to assess outcomes are scheduled at six weeks, one year, two years, and five years after surgery. During the study, researchers will monitor the number of participants using acid-reducing medication or those who require reoperations due to GERD over two years. Additional assessments include endoscopic examinations, patient-reported outcomes via questionnaires, and pH-metry tests to measure acid exposure. The study uses double-blind methods and randomization to fairly compare the two groups, with the goal of better understanding the impact of gastropexy on reflux after LSG.

Sleeve-pex: A Randomized Trial to Reduce Reflux After Sleeve Gastrectomy