Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy (EARLY): A Randomized Controlled Trial on Early Postoperative Pain

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
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• 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.

Locations
United States
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
Ricard Corcelles Codina, MD
corcelr@ccf.org
216-445-2665
Time Frame
Start Date: 2024-07-17
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 91
Treatments
Other: Laparoscopic Sleeve Gastrectomy (LSG)
Sleeve Gastrectomy completed using laparoscopic technique
Active_comparator: Robotic Sleeve Gastrectomy (RSG)
Sleeve Gastrectomy completed using robot assistance
Sponsors
Leads: Ricard Corcelles

This content was sourced from clinicaltrials.gov