Ambulatory Laparoscopic Sleeve Gastrectomy

King Saud University1,554 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,554

Conditions

Obesity, Morbid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Readmission

Readmission to hospital after discharge

Time frame: up to 12 months after surgery

Number of patients undergoing reoperative or revisional surgical or endoscopic intervention

Number of participants who underwent abdominal surgery or endoscopy for sleeve gastrectomy related complications

Time frame: up to 12 months

Hospital Transfer

Transfer of patient in Ambulatory LSG group to hospital for postop stay

Time frame: up to 16 hours

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

Number of participants who experienced postoperative complications (e.g. bleeding, staple line leaks, surgical site infection, etc...)

Time frame: within 30 days

Mortality

Postoperative 30-day mortality rate

Time frame: up to 30 days

Secondary Outcomes

Weight loss

Weight difference between baseline and follow-up visits in kilograms. Weight measured using validated, calibrated scale with minimal clothing.

Time frame: 3 months, 6 months, and 1 year