NCT06629662

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

April 3, 2025

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

October 3, 2024

Last Update Submit

March 29, 2025

Conditions

Robotic Surgery

Keywords

Robotic surgerySleeve GastrectomyBariatric surgery

Outcome Measures

Primary Outcomes (1)

  • Operative time

    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 Outcomes (8)

  • Intraoperative bleeding

    From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich

  • Postoperative bleeding

    From the end of the procedure to postoperative day 30

  • Conversion to Laparoscopy

    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

    From the end of the procedure to postoperative day 30

  • +3 more secondary outcomes

Study Arms (2)

Laparoscopic sleeve gastrectomy

ACTIVE COMPARATOR

Patients undergoing traditional sleeve gastrectomy

Procedure: Sleeve gastrectomy

Robotic sleeve gastrectomy

ACTIVE COMPARATOR

Sleeve gastrectomy with DaVinci robot

Procedure: Sleeve gastrectomy

Interventions

Sleeve gastrectomyPROCEDURE

Sleeve gastrectomy with laparoscopic or robotic approach

Laparoscopic sleeve gastrectomyRobotic sleeve gastrectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous bariatric or abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples Federico II

Naples, Italy, 80131, Italy

RECRUITING

Central Study Contacts

Antonio Vitiello, MD PhD

CONTACT

0039 0817462792antoniovitiello_@hotmail.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD Researcher

Study Record Dates

First Submitted

October 3, 2024

First Posted

October 8, 2024

Study Start

October 1, 2024

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

April 3, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

IT(1)