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

NCT02926885 | Completed DMC

• 1 other identifier: RB001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

liver; laparoscopy; Bariatric Surgery; Esophagogastric Junction; obesity

Outcome Measures

Primary Outcomes (1)

• Number of incisions made during laparoscopic surgery using flexible retractor when compared to conventional retractor

  during surgery

Study Arms (2)

CONVENTIONAL LIVER RETRACTOR DEVICE

ACTIVE COMPARATOR

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

Device: CONVENTIONAL LIVER RETRACTOR DEVICE; Procedure: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY

FLEXIBLE LIVER RETRACTOR DEVICE

EXPERIMENTAL

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

Device: FLEXIBLE LIVER RETRACTOR DEVICE; Procedure: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY

Interventions

CONVENTIONAL LIVER RETRACTOR DEVICE DEVICE

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

CONVENTIONAL LIVER RETRACTOR DEVICE

FLEXIBLE LIVER RETRACTOR DEVICE DEVICE

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

FLEXIBLE LIVER RETRACTOR DEVICE

LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY PROCEDURE

LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY

CONVENTIONAL LIVER RETRACTOR DEVICE; FLEXIBLE LIVER RETRACTOR DEVICE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara: lead

Study Sites (1)

Nucleo de Pesquisa e Desenvolvimento da Universidade Federal do Ceara

Fortaleza, Ceará, 60430-275, Brazil

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodrigo Babadopulos, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, GASTRIC SURGEON

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 6, 2016
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 7, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)