Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy

NCT06425016 | Recruiting

• 1 other identifier: 23-551
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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; Robotic Sleeve Gastrectomy; Obesity; Bariatric Surgery Candidate; Quality of Life; Laparoscopic Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

• Comparing post-operative day-1 morphine equivalent dose consumption (mg)

  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.

  24 hours post-op

Secondary Outcomes (4)

• Comparing postoperative pain score

  on postoperative days 1 (±1 days), 7 (±3 days), and 30 days (±15 days) post-op

• Comparing day-7 PROMIS scores

  7 (±3 days) and 30 days (±15 days) post-op

• Comparing rapid upper limb assessment (RULA) score in surgeons.

  intraoperative

• Improvement in Quality of life of patients

  30 days (±15 days) post-op

Other Outcomes (4)

• 30-day perioperative complications and serious adverse event incidence

  30 days (±15 days) post-op

• Length of hospital stay

  30 days (±15 days) post-op

• Number of participants with resolution of medical comorbidities

  one year post-op

Study Arms (2)

Laparoscopic Sleeve Gastrectomy (LSG)

OTHER

Sleeve Gastrectomy completed using laparoscopic technique

Procedure: Laparoscopic Sleeve Gastrectomy (LSG)

Robotic Sleeve Gastrectomy (RSG)

ACTIVE COMPARATOR

Sleeve Gastrectomy completed using robot assistance

Procedure: Robotic Sleeve Gastrectomy (RSG)

Interventions

Laparoscopic Sleeve Gastrectomy (LSG) PROCEDURE

Bariatric Surgery

Laparoscopic Sleeve Gastrectomy (LSG)

Robotic Sleeve Gastrectomy (RSG) PROCEDURE

Bariatric Surgery

Robotic Sleeve Gastrectomy (RSG)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ricard Corcelles: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Obesity

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Ricard Corcelles Codina, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricard Corcelles Codina, MD

CONTACT

216-445-2665; corcelr@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be blinded to the intervention. An equal number of identical bandages will be applied to the abdomen in similar locations following each intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Professor of Surgery, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University

Model Details: Single-blind randomized controlled trial with a 1:1 allocation ratio. The study will consist of 2 interventions: laparoscopic sleeve gastrectomy (LSG) or robotic sleeve gastrectomy (RSG). All patients will be randomized during the preoperative evaluation process. An interim analysis will be performed upon completion of the primary endpoint assessment for 91 patients to determine whether a re-estimation of the total is required. Sample size re-estimation will be planned using the conditional power method proposed by Mehta and Pocock. The 91 patients data will be used to estimate the conditional power for detecting the difference in primary outcome between two groups in the final analysis. When the conditional power is between 0.36 and 0.8, the investigators will increase the sample size accordingly, up to a sample size of 360. Otherwise, the trial will continue using the planned sample size.

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 22, 2024
• Study Start: July 17, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)