Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy (NCT06425016)
Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy (EARLY): A Randomized Controlled Trial on Early Postoperative Pain
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cleveland Clinic — Cleveland, Ohio
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
- Laparoscopic Sleeve Gastrectomy (LSG) (PROCEDURE)
- Robotic Sleeve Gastrectomy (RSG) (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Cleveland Clinic — Cleveland, Ohio
📞 Contact the Study Coordinator
Phone: (216) 445-2665
Email: corcelr@ccf.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Post Operative Pain
- ENDOblock: Bilateral Superficial Cervical Blocks With Local Wound Infiltration in Thyroid Surgery — Sacramento, California
- Quality of Recovery From Mastectomy With and Without PECS Blocks — Evanston, Illinois
- Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery — San Juan,
- Jaw Muscle Pain Post Wisdom Molar Surgery — Newark, New Jersey
- Comparison of Interscalene Catheter to Single Injection Interscalene Blocks for Total Shoulder Arthroplasties — Iowa City, Iowa
- Methadone to Reduce Chronic Opioid Use After Major Spine Surgery: The MEND Pilot Feasibility Study — Cleveland, Ohio
Explore by condition: All Post Operative Pain clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.