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Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy
Sponsor: Ricard Corcelles
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
Conditions
Interventions
Laparoscopic Sleeve Gastrectomy (LSG)
Bariatric Surgery
Robotic Sleeve Gastrectomy (RSG)
Bariatric Surgery
Locations (1)
Cleveland Clinic
Cleveland, Ohio, United States