Clinical trial NCT05106660: Ambulatory Laparoscopic Sleeve Gastrectomy
Official title: Safety and Efficacy of Same Day vs Next Day Discharge Post Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Keywords: sleeve gastrectomy
ambulatory surgery
day case surgery
Lead sponsor: King Saud University
Sponsor class: OTHER
Collaborators: name: New You Medical Center
First posted: 2021-11-04
Enrollment: 1554
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Readmission
timeFrame: up to 12 months after surgery
measure: Number of patients undergoing reoperative or revisional surgical or endoscopic intervention
timeFrame: up to 12 months
measure: Hospital Transfer
timeFrame: up to 16 hours
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
timeFrame: within 30 days
measure: Mortality
timeFrame: up to 30 days
Secondary outcomes:
measure: Weight loss
timeFrame: 3 months, 6 months, and 1 year
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: New You Medical Center
Study officials:
affiliation: New You Medical Center
name: Aayed Alqahtani, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References: