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Robotic vs Laparoscopic Sleeve Gastrectomy for Obesity (EARLY Trial)

N/A
Recruiting
Led By Ricard Corcelles Codina, MD
Research Sponsored by Ricard Corcelles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-op up to one year of follow up
Awards & highlights
No Placebo-Only Group

Summary

"This trial will look at the outcomes of two different types of weight loss surgeries, laparoscopic sleeve gastrectomy (LSG) and robotic sleeve gastrectomy (RSG), in patients who

Who is the study for?
This trial is for individuals eligible for bariatric surgery to treat obesity, as per NIH guidelines. Participants must be able to consent, be medically cleared for elective surgery, and handle general anesthesia. It's taking place at the Cleveland Clinic Bariatric and Metabolic Institute.
What is being tested?
The study compares two types of weight loss surgeries: traditional Laparoscopic Sleeve Gastrectomy (LSG) and Robotic Sleeve Gastrectomy (RSG). The main focus is on postoperative pain but also looks at surgeon comfort during operation and patient life quality after surgery.
What are the potential side effects?
Potential side effects include typical surgical risks such as infection, bleeding, reaction to anesthesia, blood clots, lung or breathing problems. Specifics will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Comparing post-operative day-1 morphine equivalent dose consumption (mg)
Secondary study objectives
Comparing day-7 PROMIS scores
Comparing postoperative pain score
Comparing rapid upper limb assessment (RULA) score in surgeons.
+1 more
Other study objectives
30-day perioperative complications and serious adverse event incidence
Length of hospital stay
Number of participants with resolution of medical comorbidities
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Laparoscopic Sleeve Gastrectomy (LSG)Experimental Treatment1 Intervention
Sleeve Gastrectomy completed using laparoscopic technique
Group II: Robotic Sleeve Gastrectomy (RSG)Active Control1 Intervention
Sleeve Gastrectomy completed using robot assistance

Find a Location

Who is running the clinical trial?

Ricard CorcellesLead Sponsor
Ricard Corcelles Codina, MDPrincipal InvestigatorThe Cleveland Clinic
~56 spots leftby Sep 2025
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