Ambulatory Laparoscopic Sleeve Gastrectomy (DAYSLEEVE)

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid
• Intervention / Treatment: Procedure: Ambulatory Laparoscopic Sleeve Gastrectomy; Procedure: Conventional 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 Type: Interventional
• Enrollment (Actual): 1554
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • New You Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: King Saud University
• Collaborators: New You Medical Center
• Investigators: Principal Investigator: Aayed Alqahtani, MD FRCSC, New You Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: sleeve gastrectomy; day case surgery; ambulatory surgery
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: NYASCLSG001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No