NCT06425016 Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy
| NCT ID | NCT06425016 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ricard Corcelles |
| Condition | Post Operative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 91 participants |
| Start Date | 2024-07-17 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 91 participants in total. It began in 2024-07-17 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Ricard Corcelles Codina, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT06425016 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Post Operative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06425016 currently recruiting?
Yes, NCT06425016 is actively recruiting participants. Contact the research team at corcelr@ccf.org for enrollment information.
Where is the NCT06425016 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06425016 clinical trial?
NCT06425016 is sponsored by Ricard Corcelles. The principal investigator is Ricard Corcelles Codina, MD at The Cleveland Clinic. The trial plans to enroll 91 participants.