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Ambulatory Laparoscopic Sleeve Gastrectomy

NCT ID: NCT05106660

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1554 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-12-01

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.

Conditions

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Obesity, Morbid

Keywords

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sleeve gastrectomy ambulatory surgery day case surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ambulatory Care Laparoscopic sleeve gastrectomy

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

Group Type EXPERIMENTAL

Ambulatory Laparoscopic Sleeve Gastrectomy

Intervention Type PROCEDURE

Same-day discharge

Next Day Discharge Laparoscopic sleeve gastrectomy

Laparoscopic sleeve gastrectomy with next day discharge

Group Type ACTIVE_COMPARATOR

Conventional Laparoscopic Sleeve Gastrectomy

Intervention Type PROCEDURE

Next-day discharge

Interventions

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Ambulatory Laparoscopic Sleeve Gastrectomy

Same-day discharge

Intervention Type PROCEDURE

Conventional Laparoscopic Sleeve Gastrectomy

Next-day discharge

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New You Medical Center

UNKNOWN

Sponsor Role collaborator

King Saud University

OTHER

Sponsor Role lead

Responsible Party

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Aayed Alqahtani

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aayed Alqahtani, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

New You Medical Center

Locations

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New You Medical Center

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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NYASCLSG001

Identifier Type: -

Identifier Source: org_study_id