Actively Recruiting
Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy (EARLY): A Randomized Controlled Trial on Early Postoperative Pain
Led by Ricard Corcelles · Updated on 2025-12-10
91
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of two types of bariatric surgery, laparoscopic sleeve gastrectomy (LSG) and robotic sleeve gastrectomy (RSG), in adults eligible for sleeve gastrectomy under NIH guidelines. This interventional trial aims to compare early postoperative pain between the two surgical approaches, as well as surgeon comfort and patient quality of life. Additional outcomes include 30-day perioperative results, complications, serious adverse events, resolution of obesity-related conditions, and weight loss one year after surgery. The study randomly assigns participants to receive either standard laparoscopic sleeve gastrectomy or robotic-assisted sleeve gastrectomy. Both procedures involve removing part of the stomach to promote weight loss, but robotic surgery offers potential benefits such as better 3D visualization and improved surgeon ergonomics. All surgeries occur at a single center, and each participant undergoes only one type of surgery during the trial. Participants will be monitored closely after surgery to assess pain levels using morphine dose consumption and pain scores at 1, 7, and 30 days post-operation. Quality of life will also be evaluated at 30 days, and surgeon ergonomics will be assessed during surgery. Researchers will track complications and medical improvements up to one year, including weight loss expressed as percent of excess weight lost. The trial will last until April 2027, with various follow-up assessments scheduled throughout the year.
CONDITIONS
Brief Title
Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible for sleeve gastrectomy based on current NIH guidelines
- Able to give consent
- Medically cleared to undergo elective surgery
- Able to tolerate general anesthesia
- Aged between 18 and 70 years
You will not qualify if you...
- Previous bariatric surgery
- Emergency surgery cases
- Chronic opioid use (daily use for at least 3 months)
- Unable to sign written consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo either robotic-assisted or laparoscopic sleeve gastrectomy followed by early post-operative care focusing on pain management.
1 surgical visit and daily assessments during hospital stay
Duration - 30 days (±15 days)
Participants are followed to assess pain, quality of life, and recovery at multiple time points after surgery.
3 follow-up visits on approximately postoperative days 1, 7, and 30
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
R
Ricard Corcelles Codina, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here