Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Ricard Corcelles
Study ID
NCT06425016
Status
Recruiting
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Conditions

  • Bariatric Surgery Candidate
  • Laparoscopic Sleeve Gastrectomy
  • Obesity
  • Post Operative Pain
  • Quality of Life
  • Robotic Sleeve Gastrectomy

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Laparoscopic Sleeve Gastrectomy (LSG) — PROCEDURE
    Bariatric Surgery
  • Robotic Sleeve Gastrectomy (RSG) — PROCEDURE
    Bariatric Surgery

Study Details

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.

Key Dates

Start date
Jul 17, 2024
Status verified
Dec 2025
Primary completion
Sep 1, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
91 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Other: Laparoscopic Sleeve Gastrectomy (LSG)
    Sleeve Gastrectomy completed using laparoscopic technique
  • Active Comparator: Robotic Sleeve Gastrectomy (RSG)
    Sleeve Gastrectomy completed using robot assistance

Primary Outcome Measure

Comparing post-operative day-1 morphine equivalent dose consumption (mg) [ Time Frame: 24 hours post-op ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Chytaine Hall
[email protected]
216-445-3983

Find similar trials in Cleveland, OH

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Cleveland Clinic· Cleveland, OH

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