Ambulatory Laparoscopic Sleeve Gastrectomy

Obesity, Morbid Clinical Trial

— DAYSLEEVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05106660
• Other study ID #: NYASCLSG001
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: November 2021
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1554
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Procedure:
• Ambulatory Laparoscopic Sleeve Gastrectomy
Same-day discharge
• Conventional Laparoscopic Sleeve Gastrectomy
Next-day discharge

Locations

Country	Name	City	State
Saudi Arabia	New You Medical Center	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
King Saud University	New You Medical Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmission	Readmission to hospital after discharge	up to 12 months after surgery
Primary	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
Primary	Hospital Transfer	Transfer of patient in Ambulatory LSG group to hospital for postop stay	up to 16 hours
Primary	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
Primary	Mortality	Postoperative 30-day mortality rate	up to 30 days
Secondary	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