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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926885
• Other study ID #: RB001
• Status: Completed
• Phase: N/A
• First received: October 5, 2016
• Last updated: October 6, 2016
• Start date: August 2015
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• CONVENTIONAL LIVER RETRACTOR DEVICE
LIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING CONVENTIONAL RETRACTOR DEVICE
• FLEXIBLE LIVER RETRACTOR DEVICE
LIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING FLEXIBLE LIVER RETRACTOR DEVICE

Procedure:
• LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY

Locations

Country	Name	City	State
Brazil	Nucleo de Pesquisa e Desenvolvimento da Universidade Federal do Ceara	Fortaleza	CE

Sponsors (1)

Lead Sponsor	Collaborator
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of incisions made during laparoscopic surgery using flexible retractor when compared to conventional retractor		during surgery	No