Effects of Bougie Size on Safety and Outcomes in Laparoscopic Sleeve Gastrectomy A Randomized Trial Comparing Larger >40-Fr and Standard 36-Fr Calibration Tubes

What this Trial Is About

Laparoscopic sleeve gastrectomy LSG is a common weight loss surgery that involves removing part of the stomach to create a smaller, narrow stomach sleeve. This procedure helps patients lose weight and improve related health problems. Researchers are studying the impact of different bougie sizes, which are tubes used to shape the stomach during surgery, to find the best balance between safety and weight loss outcomes. The study compares smaller bougies 36-Fr and larger bougies over 40-Fr in a randomized controlled trial. Participants will be randomly assigned to receive LSG with either a larger calibration bougie >40-Fr or a standard smaller bougie 36-Fr. The study devices are medical-grade, single-use calibration tubes. The trial will assess surgical outcomes including complications, weight loss, quality of life, food tolerance, pain levels, and hospital stay length. Follow-up will include upper gastrointestinal evaluations and nutritional assessments over one year. Participants will undergo detailed assessments before and after surgery, including questionnaires about quality of life and food tolerance, weight measurements, pain scoring, and monitoring for complications such as gastric leaks within three months. Nutritional labs and upper GI studies will be done at several points up to one year. The study aims to capture comprehensive data on safety, recovery, and long-term effects of bougie size on surgery outcomes.

Bougie Diameter on Outcomes in Laparoscopic Sleeve Gastrectomy