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Ambulatory Laparoscopic Sleeve Gastrectomy (DAYSLEEVE)

Primary Purpose

Obesity, Morbid

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Ambulatory Laparoscopic Sleeve Gastrectomy
Conventional Laparoscopic Sleeve Gastrectomy
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring sleeve gastrectomy, ambulatory surgery, day case surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • New You Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ambulatory Care Laparoscopic sleeve gastrectomy

Next Day Discharge Laparoscopic sleeve gastrectomy

Arm Description

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

Laparoscopic sleeve gastrectomy with next day discharge

Outcomes

Primary Outcome Measures

Readmission
Readmission to hospital after discharge
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
Hospital Transfer
Transfer of patient in Ambulatory LSG group to hospital for postop stay
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...)
Mortality
Postoperative 30-day mortality rate

Secondary Outcome Measures

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

Full Information

First Posted
October 13, 2021
Last Updated
November 3, 2021
Sponsor
King Saud University
Collaborators
New You Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05106660
Brief Title
Ambulatory Laparoscopic Sleeve Gastrectomy
Acronym
DAYSLEEVE
Official Title
Safety and Efficacy of Same Day vs Next Day Discharge Post Sleeve Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University
Collaborators
New You Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
sleeve gastrectomy, ambulatory surgery, day case surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1554 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ambulatory Care Laparoscopic sleeve gastrectomy
Arm Type
Experimental
Arm Description
Laparoscopic sleeve gastrectomy as ambulatory care procedure with same-day discharge
Arm Title
Next Day Discharge Laparoscopic sleeve gastrectomy
Arm Type
Active Comparator
Arm Description
Laparoscopic sleeve gastrectomy with next day discharge
Intervention Type
Procedure
Intervention Name(s)
Ambulatory Laparoscopic Sleeve Gastrectomy
Intervention Description
Same-day discharge
Intervention Type
Procedure
Intervention Name(s)
Conventional Laparoscopic Sleeve Gastrectomy
Intervention Description
Next-day discharge
Primary Outcome Measure Information:
Title
Readmission
Description
Readmission to hospital after discharge
Time Frame
up to 12 months after surgery
Title
Number of patients undergoing reoperative or revisional surgical or endoscopic intervention
Description
Number of participants who underwent abdominal surgery or endoscopy for sleeve gastrectomy related complications
Time Frame
up to 12 months
Title
Hospital Transfer
Description
Transfer of patient in Ambulatory LSG group to hospital for postop stay
Time Frame
up to 16 hours
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Description
Number of participants who experienced postoperative complications (e.g. bleeding, staple line leaks, surgical site infection, etc...)
Time Frame
within 30 days
Title
Mortality
Description
Postoperative 30-day mortality rate
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
Weight loss
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aayed Alqahtani, MD FRCSC
Organizational Affiliation
New You Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New You Medical Center
City
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

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Ambulatory Laparoscopic Sleeve Gastrectomy

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