Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy
Recruiting now · Not applicable
Conditions studied: Post Operative Pain, Laparoscopic Sleeve Gastrectomy, Robotic Sleeve Gastrectomy, Obesity, Bariatric Surgery Candidate, Quality of Life
In brief
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.
Key facts
- Study ID
- NCT06425016
- Run by
- Ricard Corcelles
- People needed
- 91
- Starts
- 2024-07-17
- Expected to finish
- 2027-04-30
- Last updated by the study team
- 2025-12-10
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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