What this study is
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's being tested
- Laparoscopic Sleeve Gastrectomy (LSG)
Intervention · PROCEDURE
- Robotic Sleeve Gastrectomy (RSG)
Intervention · PROCEDURE
Both interventions
Bariatric Surgery
Study details
- Official title
- Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy (EARLY): A Randomized Controlled Trial on Early Postoperative Pain
- Sponsor
- Ricard Corcelles
- Conditions
- Post Operative Pain · Laparoscopic Sleeve Gastrectomy · Robotic Sleeve Gastrectomy · Obesity · Bariatric Surgery Candidate · Quality of Life
- Enrolling
- 91 people
- Starts
- 2024-07-17
- Est. completion
- 2027-04-30
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 70 YearsSex ALLHealthy volunteers AcceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 open- Recruiting
Study team
Sponsor
Ricard Corcelles
Study ID 23-551
Principal investigator
Ricard Corcelles Codina, MD
The Cleveland Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.