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Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy

NCT06425016 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-12-10

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Laparoscopic Sleeve Gastrectomy (LSG)

Bariatric Surgery

PROCEDURE

Robotic Sleeve Gastrectomy (RSG)

Bariatric Surgery

Sponsors & Collaborators

  • Ricard Corcelles

    lead OTHER

Principal Investigators

  • Ricard Corcelles Codina, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-17
Primary Completion
2026-09-01
Completion
2027-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06425016 on ClinicalTrials.gov