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

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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CONVENTIONAL LIVER RETRACTOR DEVICE

USE OF CONVENTIONAL LIVER RETRACTOR FOR THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY

Group Type ACTIVE_COMPARATOR

CONVENTIONAL LIVER RETRACTOR DEVICE

Intervention Type DEVICE

LIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING CONVENTIONAL RETRACTOR DEVICE

LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY

Intervention Type PROCEDURE

LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY

FLEXIBLE LIVER RETRACTOR DEVICE

USE OF THE FLEXIBLE LIVER RETRACTOR FOR THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY

Group Type EXPERIMENTAL

FLEXIBLE LIVER RETRACTOR DEVICE

Intervention Type DEVICE

LIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING FLEXIBLE LIVER RETRACTOR DEVICE

LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY

Intervention Type PROCEDURE

LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY

Interventions

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CONVENTIONAL LIVER RETRACTOR DEVICE

LIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING CONVENTIONAL RETRACTOR DEVICE

Intervention Type DEVICE

FLEXIBLE LIVER RETRACTOR DEVICE

LIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING FLEXIBLE LIVER RETRACTOR DEVICE

Intervention Type DEVICE

LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No