Robotic Versus Laparoscopic Sleeve Gastrectomy

NCT ID: NCT06629662

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Robotic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic sleeve gastrectomy

Patients undergoing traditional sleeve gastrectomy

Group Type ACTIVE_COMPARATOR

Sleeve gastrectomy

Intervention Type PROCEDURE

Sleeve gastrectomy with laparoscopic or robotic approach

Robotic sleeve gastrectomy

Sleeve gastrectomy with DaVinci robot

Group Type ACTIVE_COMPARATOR

Sleeve gastrectomy

Intervention Type PROCEDURE

Sleeve gastrectomy with laparoscopic or robotic approach

Interventions

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Sleeve gastrectomy

Sleeve gastrectomy with laparoscopic or robotic approach

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Naples

OTHER

Sponsor Role lead

Responsible Party

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Antonio Vitiello

MD PhD Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Naples Federico II

Naples, Italy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Antonio Vitiello, MD PhD

Role: CONTACT

0039 0817462792 ext. 0039

Facility Contacts

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antonio vitiello, researcher

Role: primary

0039 0817462792

Other Identifiers

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187/2023

Identifier Type: -

Identifier Source: org_study_id

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