RecruitingNot ApplicableNCT06425016

Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy

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


Sponsor

Ricard Corcelles

Enrollment

91 participants

Start Date

Jul 17, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria1

  • 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 Criteria1

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURELaparoscopic Sleeve Gastrectomy (LSG)

Bariatric Surgery

PROCEDURERobotic Sleeve Gastrectomy (RSG)

Bariatric Surgery


Locations(1)

Cleveland Clinic

Cleveland, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06425016


Related Trials