Ambulatory Laparoscopic Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Obesity, Morbid
• Interventions: Procedure: Ambulatory Laparoscopic Sleeve Gastrectomy; Procedure: Conventional Laparoscopic Sleeve Gastrectomy

• Registration Number: NCT05106660
• Lead Sponsor: King Saud University

Brief 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.

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Study First Submitted: 2021-10-13
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-03
• Last Update Submitted: 2021-11-03
• Study First Posted: 2021-11-04
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1554

Inclusion Criteria

1. Age between 18 and 65 years
2. Body mass index <60
3. American Anesthesiologists Association classification ≤III
4. Commitment to stay within close proximity to the ambulatory surgery center for 4 days after surgery

Exclusion Criteria

1. High risk for thromboembolic disease
2. Has a history of major open abdominal surgery
3. Bleeding disorders
4. Heart disease
5. Pulmonary hypertension
6. Uncontrolled type 2 diabetes
7. Severe obstructive sleep apnea
8. Chronic obstructive pulmonary disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambulatory Care Laparoscopic sleeve gastrectomy	Ambulatory Laparoscopic Sleeve Gastrectomy	Laparoscopic sleeve gastrectomy as ambulatory care procedure with same-day discharge
Next Day Discharge Laparoscopic sleeve gastrectomy	Conventional Laparoscopic Sleeve Gastrectomy	Laparoscopic sleeve gastrectomy with next day discharge

Primary Outcome Measures

Name	Time	Method
Readmission	up to 12 months after surgery	Readmission to hospital after discharge
Hospital Transfer	up to 16 hours	Transfer of patient in Ambulatory LSG group to hospital for postop stay
Mortality	up to 30 days	Postoperative 30-day mortality rate
Number of patients undergoing reoperative or revisional surgical or endoscopic intervention	up to 12 months	Number of participants who underwent abdominal surgery or endoscopy for sleeve gastrectomy related complications
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0	within 30 days	Number of participants who experienced postoperative complications (e.g. bleeding, staple line leaks, surgical site infection, etc...)

Secondary Outcome Measures

Name	Time	Method
Weight loss	3 months, 6 months, and 1 year	Weight difference between baseline and follow-up visits in kilograms. Weight measured using validated, calibrated scale with minimal clothing.

Trial Locations

Locations (1)

New You Medical Center; 🇸🇦 Riyadh, Saudi Arabia