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Completed

NCT Number: NCT05106660

Ambulatory Laparoscopic 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.

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Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New You Medical Center

Riyadh, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambulatory Laparoscopic Sleeve Gastrectomy

Procedure

Same-day discharge

Conventional Laparoscopic Sleeve Gastrectomy

Procedure

Next-day discharge

Primary outcomes

  1. Readmission

    Time frame: up to 12 months after surgery

    Readmission to hospital after discharge

  2. Number of patients undergoing reoperative or revisional surgical or endoscopic intervention

    Time frame: up to 12 months

    Number of participants who underwent abdominal surgery or endoscopy for sleeve gastrectomy related complications

  3. Hospital Transfer

    Time frame: up to 16 hours

    Transfer of patient in Ambulatory LSG group to hospital for postop stay

  4. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    Time frame: within 30 days

    Number of participants who experienced postoperative complications (e.g. bleeding, staple line leaks, surgical site infection, etc...)

  5. Mortality

    Time frame: up to 30 days

    Postoperative 30-day mortality rate

Secondary outcomes

  1. Weight loss

    Time frame: 3 months, 6 months, and 1 year

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

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Collaborators

  • New You Medical Center

Registry information

Official study title

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

Acronym: DAYSLEEVE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 4, 2021
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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