NCT05106660

Ambulatory Laparoscopic Sleeve Gastrectomy

Safety and Efficacy of Same Day vs Next Day Discharge Post Sleeve Gastrectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,554 (actual)
• Sponsor: King Saud University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In the era of laparoscopic surgery, day case procedures are increasingly practiced around the world, however, day case bariatric surgery remains a controversial issue due to lack of sufficient evidence evaluating its safety. Laparoscopic sleeve gastrectomy (LSG) is currently the most popular bariatric surgery performed worldwide, and the standard is 1-2 days postop stay. However, the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery released guidelines in 2016 that allowed LSG in ambulatory surgery centers for low acuity patients. In the present trial, investigators will compare the safety and feasibility of same day discharge vs next day discharge in a large group of patients undergoing laparoscopic sleeve gastrectomy.

Detailed description

This is a 2-group, randomized, open label clinical trial patients who will be recruited at an ASC to undergo LSG with same-day discharge, termed Ambulatory Surgery Center LSG (ASC LSG) or LSG with conventional hospitalization and next day discharge (CH LSG). The study will recruit participants between December 2018 and December 2020. Data collected will include including age, body mass index (BMI), operative time, recovery room time, hospital stay, readmission, follow up visits, ASC visits, adverse events, and re-operation rates.

Conditions

• Obesity, Morbid

Interventions

Type	Name	Description
PROCEDURE	Ambulatory Laparoscopic Sleeve Gastrectomy	Same-day discharge
PROCEDURE	Conventional Laparoscopic Sleeve Gastrectomy	Next-day discharge

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2021-11-04
• Last updated: 2021-11-04

Locations

1 site across 1 country: Saudi Arabia