Comparing robotic and laparoscopic sleeve gastrectomy for obesity treatment
Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy (EARLY): A Randomized Controlled Trial on Early Postoperative Pain
This study is testing whether robotic sleeve gastrectomy works better than laparoscopic sleeve gastrectomy for people with obesity in terms of pain, recovery, and quality of life after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 91 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06425016 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, single-blind randomized controlled trial that aims to compare the effects of laparoscopic sleeve gastrectomy (LSG) and robotic sleeve gastrectomy (RSG) on postoperative pain, surgeon ergonomics, and patient quality of life. Eligible patients will be those who meet the National Institute of Health guidelines for bariatric surgery and are medically cleared for elective surgery. The study will evaluate various outcomes, including 30-day perioperative results, morbidities, serious adverse events, and weight loss. All procedures will be conducted at the Cleveland Clinic Bariatric and Metabolic Institute.
Who should consider this trial
Good fit: Ideal candidates for this study are patients eligible for laparoscopic sleeve gastrectomy according to NIH guidelines who can provide consent and tolerate general anesthesia.
Not a fit: Patients with previous bariatric surgeries, chronic opioid use, or those unable to sign consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative pain management and enhanced recovery for patients undergoing bariatric surgery.
How similar studies have performed: Other studies have shown promising results with robotic surgery in various specialties, indicating potential benefits in bariatric surgery as well.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Ricard Corcelles Codina, MD — The Cleveland Clinic
- Study coordinator: Ricard Corcelles Codina, MD
- Email: corcelr@ccf.org
- Phone: 216-445-2665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.