Ambulatory Laparoscopic Sleeve Gastrectomy (DAYSLEEVE)

King Saud University

Status: Completed

Conditions: Obesity, Morbid

Treatments: Procedure: Ambulatory Laparoscopic Sleeve Gastrectomy; Procedure: Conventional Laparoscopic Sleeve Gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05106660

NYASCLSG001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,554 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,554 participants in 2 patient groups

Ambulatory Care Laparoscopic sleeve gastrectomy

Experimental group

Description:

Laparoscopic sleeve gastrectomy as ambulatory care procedure with same-day discharge

Treatment:

Procedure: Ambulatory Laparoscopic Sleeve Gastrectomy

Next Day Discharge Laparoscopic sleeve gastrectomy

Active Comparator group

Description:

Laparoscopic sleeve gastrectomy with next day discharge

Treatment:

Procedure: Conventional Laparoscopic Sleeve Gastrectomy