Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy

RecruitingHealthy volunteers welcome

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

Who can join

Ages 18 to 70 · All sexes · Healthy volunteers welcome

Full eligibility criteria

Inclusion Criteria:

* All patients eligible to undergo a SG 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.

Exclusion Criteria:

* patients with previous bariatric surgeries, emergency surgeries, with chronic opioid use (daily use of opioids for at least 3 months), and those who are not able to sign the written consent form.

About the study

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.

What is being tested

Laparoscopic Sleeve Gastrectomy (LSG) (procedure)
Robotic Sleeve Gastrectomy (RSG) (procedure)

Sponsor: Ricard Corcelles · Participants: 91 · Started: Jul 17, 2024

Contact the study team

Ricard Corcelles Codina, MD · Phone: 216-445-2665

Official record on ClinicalTrials.gov — NCT06425016

Locations in the U.S.

Ohio	Cleveland Clinic, Cleveland

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.