Efficacy Evaluation of the Esophagogastric Junction Exposure Obtained by the Flexible Liver Retractor in Gastroplasty

October 6, 2016 updated by: RODRIGO FEITOSA DE ALBUQUERQUE LIMA BABADOPULOS, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

Efficacy Evaluation of the Esophagogastric Junction Exposure Obtained by the Flexible Liver Retractor in Gastroplasty for Obesity

Evaluation of a new technique of liver retraction for the exposure of the His angle in gastric bypass Roux-en-Y surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obesity is a chronic disease of clinical treatment initially, but with precise surgical indications regulated by national and international health organizations. Among the surgical techniques, the gastric bypass Roux-en-Y is considered the "gold standard" for its efficiency and low morbidity and mortality. In gastric laparoscopic surgery it is necessary to move the liver in order to ensure adequate working space and a good view. Conventional laparoscopic retractors surgery are generally coarse, require an additional incision for its installation, or handling by an assistant during surgery and involve risk of liver injury. The objective of this study was to evaluate the efficacy of a flexible liver retractor in the exposure of the His angle in Roux-en-Y gastric bypass for morbid obesity. This was a prospective, controlled, open and comparative study, with 100 patients randomly divided into two groups (conventional and flexible retractor), with medical indication for bariatric surgery. Data were recorded during surgery in both groups for comparison of the two hepatic retraction techniques.

Study Type

Interventional

Enrollment (Actual)

100

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 Locations

  • Brazil
    • CE
      • Fortaleza, CE, Brazil, 60430-275
        • Nucleo de Pesquisa e Desenvolvimento da Universidade Federal do Ceara

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between 18 - 65 years, both genders, with indication of bariatric surgery according to IFSO criteria.
  • Agreed to participate and signed informed consent form.

Exclusion Criteria:

  • Patients who did not agree to participate and / or any other condition that the investigator judged relevant for not participating in the study were excluded.

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CONVENTIONAL LIVER RETRACTOR DEVICE
USE OF CONVENTIONAL LIVER RETRACTOR FOR THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
Device: CONVENTIONAL LIVER RETRACTOR DEVICE
LIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING CONVENTIONAL RETRACTOR DEVICE
Procedure: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
Experimental: FLEXIBLE LIVER RETRACTOR DEVICE
USE OF THE FLEXIBLE LIVER RETRACTOR FOR THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
Procedure: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
Device: FLEXIBLE LIVER RETRACTOR DEVICE
LIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING FLEXIBLE LIVER RETRACTOR DEVICE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of incisions made during laparoscopic surgery using flexible retractor when compared to conventional retractor
Time Frame: during surgery
during surgery

Collaborators and Investigators

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

Sponsor

Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

Investigators

  • Principal Investigator: Rodrigo Babadopulos, MD, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

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

August 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Estimate)

October 7, 2016

Last Update Submitted That Met QC Criteria

October 6, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RB001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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