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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Device: CONVENTIONAL LIVER RETRACTOR DEVICE; Device: FLEXIBLE LIVER RETRACTOR DEVICE; Procedure: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY

• Registration Number: NCT02926885
• Lead Sponsor: Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

Brief Summary

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

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 Timeline

• Study Start: 2015-08
• Primary Completion: 2016-07
• Study Completion: 2016-08
• Status Verified: 2016-10
• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONVENTIONAL LIVER RETRACTOR DEVICE	CONVENTIONAL LIVER RETRACTOR DEVICE	USE OF CONVENTIONAL LIVER RETRACTOR FOR THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
FLEXIBLE LIVER RETRACTOR DEVICE	LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY	USE OF THE FLEXIBLE LIVER RETRACTOR FOR THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
CONVENTIONAL LIVER RETRACTOR DEVICE	LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY	USE OF CONVENTIONAL LIVER RETRACTOR FOR THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
FLEXIBLE LIVER RETRACTOR DEVICE	FLEXIBLE LIVER RETRACTOR DEVICE	USE OF THE FLEXIBLE LIVER RETRACTOR FOR THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY

Primary Outcome Measures

Name	Time	Method
Number of incisions made during laparoscopic surgery using flexible retractor when compared to conventional retractor	during surgery

Trial Locations

Locations (1)

Nucleo de Pesquisa e Desenvolvimento da Universidade Federal do Ceara; 🇧🇷 Fortaleza, CE, Brazil