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RECRUITING
NCT06425016
NA

Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy

Sponsor: Ricard Corcelles

View on ClinicalTrials.gov

Summary

This will be a prospective, obesity-registry based, single-blind randomized controlled trial with a 1:1 allocation ratio. Specific inclusion criteria are all patients eligible to undergo a Laparoscopic sleeve gastrectomy (LSG) based on the current National Institute of Health (NIH) patient selection guidelines. Patients should be able to give consent, be deemed medically-cleared to undergo elective surgery, and tolerate general anesthesia. All enrollments and surgeries in this study will take place at the Cleveland Clinic Bariatric and Metabolic Institute. The study will consist of 2 interventions: laparoscopic sleeve gastrectomy (LSG) or robotic sleeve gastrectomy (RSG). The primary objective is early postoperative pain, but also surgeon ergonomics and patient quality of life will be compared. Additional outcomes include 30-day perioperative results, minor and major morbidities, serious adverse events, resolution of medical comorbidities, and weight loss in percent of excess weight lost (%EWL) at one year.

Official title: Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy (EARLY): A Randomized Controlled Trial on Early Postoperative Pain

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

91

Start Date

2024-07-17

Completion Date

2027-04-30

Last Updated

2025-12-10

Healthy Volunteers

Yes

Interventions

PROCEDURE

Laparoscopic Sleeve Gastrectomy (LSG)

Bariatric Surgery

PROCEDURE

Robotic Sleeve Gastrectomy (RSG)

Bariatric Surgery

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States