NCT06425016Recruiting
Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy
Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy (EARLY): A Randomized Controlled Trial on Early Postoperative Pain
Source: ClinicalTrials.gov · Last updated 10 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 91 (estimated)
- First submitted
- 24 Apr 2024
- Start date
- 17 Jul 2024
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Ricard Corcelles
- Diseases
- Obesity
- NCT number
- NCT06425016
What you commit to
- Study type: Interventional
- Planned participants: 91
- From 17 Jul 2024 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.