Randomized Trial Comparing Laparoscopic Roux-en-y Gastric Bypass to Micro-laparoscopic Roux-en-y Gastric Bypass

Study Summary

Background Laparoscopy is the preferred surgical approach for a number of different diseases as it allows for diagnosis and treatment in the setting of a safe and feasible method offering enhanced cosmesis. The natural evolution of laparoscopy is micro-laparoscopy which utilizes smaller instruments and optics. Technological advancements have enabled miniaturization of the surgical equipment without compromising diagnostic or operative capabilities. Dr. Keith Zuccala is currently performing micro-laparoscopic gastric bypass with an identical safety profile as traditional laparoscopy (NSQIP data comparison between Dr. Laura Choi and Dr. Keith Zuccala). The current trend in laparoscopy is to minimize incisions and their size to decrease trauma to the abdominal wall. Study Design Both methods have never been compared in a prospective randomized trial to address the following questions. 1. Is there a difference in outcome? 2. Is there a decrease in postoperative pain? 3. Does it decrease time off from work? 4. Does micro-laparoscopy increase OR time? 5. What is the effect on cost of micro-laparoscopy? Patients will be randomized to one or the other method, disclosing that to the investigators best knowledge both methods are equally safe and that Dr. Zuccala has performed several hundred cases using both methods. Patient Population Projected sample size would be 50 patients in each group. Accrual should be feasible over the course of 9-12 months. Data collection (patients will be followed for a total of 30 days for the purpose of this study) 1. NSQIP data to assess outcome 2. Postoperative usage of pain medication while in the hospital 3. Time off from work 4. OR time 5. Direct cost of procedure as it relates to material used

Conditions Studied

Interventions

• PROCEDURE Laparoscopic Surgery
• PROCEDURE Microlaparoscopic gastric bypass

Study Locations (1)