Recruiting

Assisted Robotic vs Laparoscopic

Sponsor:

Ricard Corcelles

Code:

NCT06425016

Conditions

Post Operative Pain

Laparoscopic Sleeve Gastrectomy

Robotic Sleeve Gastrectomy

Obesity

Bariatric Surgery Candidate

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Laparoscopic Sleeve Gastrectomy (LSG)

Robotic Sleeve Gastrectomy (RSG)

Study Details

Brief 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.

Conditions

Post Operative Pain

Laparoscopic Sleeve Gastrectomy

Robotic Sleeve Gastrectomy

Obesity

Bariatric Surgery Candidate

Study ID

NCT06425016

Start date

Jul 17, 2024

Status verified date

Dec, 2025

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

91 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Laparoscopic Sleeve Gastrectomy (LSG)

Sleeve Gastrectomy completed using laparoscopic technique

active comparator: Robotic Sleeve Gastrectomy (RSG)

Sleeve Gastrectomy completed using robot assistance

Interventions

Laparoscopic Sleeve Gastrectomy (LSG)

Bariatric Surgery

Robotic Sleeve Gastrectomy (RSG)

Bariatric Surgery

Primary outcome measure

  • Comparing post-operative day-1 morphine equivalent dose consumption (mg) [ Time Frame: 24 hours post-op ]

Central Contacts and Locations

Central contacts

Ricard Corcelles Codina, MD

216-445-2665corcelr@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

More Information

Sponsor

Ricard Corcelles

Last update posted

Dec 10, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ricard Corcelles on 2025-12-10.