Clinical trial

Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy

Recruiting now · Not applicable · 1 countries · Registry ID NCT06425016

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersAccepted

ConditionPost Operative Pain, Laparoscopic Sleeve Gastrectomy, Robotic Sleeve Gastrectomy, Obesity, Bariatric Surgery Candidate, Quality of Life

Full registry 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.

Treatments and study arms

Laparoscopic Sleeve Gastrectomy (LSG)

Procedure

Bariatric Surgery

Robotic Sleeve Gastrectomy (RSG)

Procedure

Bariatric Surgery

Primary outcomes

Comparing post-operative day-1 morphine equivalent dose consumption (mg)24 hours post-op

To determine if patients with obesity planned for robotic sleeve gastrectomy experience a decrease in opioid consumption (Morphine Equivalent Dose) in mg on postoperative day 1 compared to patients undergoing laparoscopic sleeve gastrectomy.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Cleveland Clinic🇺🇸 Cleveland, Ohio, United States

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Chytaine HallContact

Email · Call 216-445-3983