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

Study Overview
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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.

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.

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

Conditions
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Obesity

Intervention / Treatment
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* Device: CONVENTIONAL LIVER RETRACTOR DEVICE
* Device: FLEXIBLE LIVER RETRACTOR DEVICE
* Procedure: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver, laparoscopy, Bariatric Surgery, Esophagogastric Junction, obesity