Robotic Versus Laparoscopic Sleeve Gastrectomy (SLEEVEROBOP)

March 29, 2025 updated by: Antonio Vitiello, University of Naples

Robotic Versus Laparoscopic Sleeve Gastrectomy: Prospective Randomized Study.

Sleeve gastrectomy is the most commonly performed bariatric procedures. Robotic surgery seems to add more precision to the surgical interventions. However, robotic bariatric procedures appear to be burdened by longer operative time.

Aim of the investigators is to prospectively and randomly submit patients suffering from obesity to robotic or laparoscopic surgery in order to compare outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Naples, Italy, 80131
        • Recruiting
        • University of Naples Federico II
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • According to IFSO (International Federation for the Surgery of Obesity)/ASMBS (American Society for Metabolic and Bariatric Surgery) 2023 guidelines

Exclusion Criteria:

  • Previous bariatric or abdominal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laparoscopic sleeve gastrectomy
Patients undergoing traditional sleeve gastrectomy
Procedure: Sleeve gastrectomy
Sleeve gastrectomy with laparoscopic or robotic approach
Active Comparator: Robotic sleeve gastrectomy
Sleeve gastrectomy with DaVinci robot
Procedure: Sleeve gastrectomy
Sleeve gastrectomy with laparoscopic or robotic approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Operative time in minutes (Docking plus console time for the robotic procedures)
From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative bleeding
Time Frame: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Bleeding during the surgical procedure
From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Postoperative bleeding
Time Frame: From the end of the procedure to postoperative day 30
Bleeding after the end of the procedure
From the end of the procedure to postoperative day 30
Conversion to Laparoscopy
Time Frame: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Conversion to laparoscopy
From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Conversion to Laparotomy
Time Frame: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Conversion to laparotomy
From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Postoperative Leak
Time Frame: From the end of the procedure to postoperative day 30
Leak from the staple line
From the end of the procedure to postoperative day 30
Postoperative Bowel Obstruction
Time Frame: From the end of the procedure to postoperative day 30
Bowel obstruction
From the end of the procedure to postoperative day 30
Postoperative nausea
Time Frame: From the end of the procedure to postoperative hour 24
Postoperative nausea measured with a Visuo Analogic Scale (VAS) from 0 (no nausea) to 10 (not tolerable nausea)
From the end of the procedure to postoperative hour 24
Postoperative vomit
Time Frame: From the end of the procedure to postoperative hour 24
Postoperative vomit measured with a Visuo Analogic Scale (VAS) from 0 (no nausea) to 10 (not tolerable vomit)
From the end of the procedure to postoperative hour 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Naples

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 29, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 187/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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