Robotic Versus Laparoscopic Roux En-y Gastric Bypass

February 23, 2023 updated by: Giovanna Pavone, University of Foggia

Can Robotic Gastric Bypass be Considered a Valid Alternative to Laparoscopy: Our Early Experience

This study retrospectively identified 33 consecutive obese patients who underwent either laparoscopic or robotic gastric bypass procedures over a 2-year period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

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

Study Locations

  • Italy
      • Foggia, Italy, 71122
        • University of Foggia

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity or BMI≥40kg/m2, age ≥ 18 years. Before surgery, patients underwent a standardized psychological and physical evaluation which includes blood chemistry tests, chest x-rays, electrocardiogram and cardiological examinations, nutritional evaluation, esophagogastroduodenoscopy, spirometry and psychiatric evaluation .

Description

Inclusion Criteria:

  • Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity
  • BMI≥40kg/m2, age ≥ 18 years.

Exclusion Criteria:

  • Re-do surgery procedures

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obese patients underwent laparoscopic gastric bypass
Procedure: Roux en-Y gastric bypass
gastric bypass with jejuna-jenual anastomosis and gusto-jejunal anastomosis
obese patients underwent robotic gastric bypass
Procedure: Roux en-Y gastric bypass
gastric bypass with jejuna-jenual anastomosis and gusto-jejunal anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
differences between the robotic and laparoscopic gastric bypass
Time Frame: two years period
incidence of mortality and morbidity (percentage)
two years period
differences between the robotic and laparoscopic gastric bypass
Time Frame: two years period
BMI ( kg/m2)
two years period
differences between the robotic and laparoscopic gastric bypass
Time Frame: two years period
age (years)
two years period
differences between the robotic and laparoscopic gastric bypass
Time Frame: two years period
weight (kg)
two years period

Collaborators and Investigators

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

Sponsor

University of Foggia

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)

January 1, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

January 15, 2023

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Estimate)

February 28, 2023

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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