NCT05106660

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,554

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
Last Updated

November 4, 2021

Status Verified

November 1, 2021

Enrollment Period

2 years

First QC Date

October 13, 2021

Last Update Submit

November 3, 2021

Conditions

Obesity, Morbid

Keywords

sleeve gastrectomyambulatory surgeryday case surgery

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • Weight loss

    3 months, 6 months, and 1 year

Study Arms (2)

Ambulatory Care Laparoscopic sleeve gastrectomy

EXPERIMENTAL

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

Procedure: Ambulatory Laparoscopic Sleeve Gastrectomy

Next Day Discharge Laparoscopic sleeve gastrectomy

ACTIVE COMPARATOR

Laparoscopic sleeve gastrectomy with next day discharge

Procedure: Conventional Laparoscopic Sleeve Gastrectomy

Interventions

Ambulatory Laparoscopic Sleeve GastrectomyPROCEDURE

Same-day discharge

Ambulatory Care Laparoscopic sleeve gastrectomy
Conventional Laparoscopic Sleeve GastrectomyPROCEDURE

Next-day discharge

Next Day Discharge Laparoscopic sleeve gastrectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New You Medical Center

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aayed Alqahtani, MD FRCSC

    New You Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

October 13, 2021

First Posted

November 4, 2021

Study Start

December 1, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

November 4, 2021

Record last verified: 2021-11

Locations

SA(1)