Ambulatory Laparoscopic Sleeve Gastrectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Morbid

Intervention / Treatment
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* Procedure: Ambulatory Laparoscopic Sleeve Gastrectomy
* Procedure: Conventional Laparoscopic Sleeve Gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 65 years Body mass index <60 American Anesthesiologists Association classification ≤III Commitment to stay within close proximity to the ambulatory surgery center for 4 days after surgery Exclusion Criteria: High risk for thromboembolic disease Has a history of major open abdominal surgery Bleeding disorders Heart disease Pulmonary hypertension Uncontrolled type 2 diabetes Severe obstructive sleep apnea Chronic obstructive pulmonary disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambulatory Care Laparoscopic sleeve gastrectomy<br>Laparoscopic sleeve gastrectomy as ambulatory care procedure with same-day discharge | Procedure: Ambulatory Laparoscopic Sleeve Gastrectomy<br>* Same-day discharge<br>|
| Active Comparator: Next Day Discharge Laparoscopic sleeve gastrectomy<br>Laparoscopic sleeve gastrectomy with next day discharge | Procedure: Conventional Laparoscopic Sleeve Gastrectomy<br>* Next-day discharge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission | Readmission to hospital after discharge | 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 | up to 12 months | 
| Hospital Transfer | Transfer of patient in Ambulatory LSG group to hospital for postop stay | 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...) | within 30 days | 
| Mortality | Postoperative 30-day mortality rate | up to 30 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleeve gastrectomy, ambulatory surgery, day case surgery