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Clinical Trials/NCT02926885
NCT02926885CompletedNot Applicable

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

Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara1 site in 1 country100 target enrollmentStarted: August 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Number of incisions made during laparoscopic surgery using flexible retractor when compared to conventional retractor

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

CONVENTIONAL LIVER RETRACTOR DEVICE

Active Comparator

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

Intervention: CONVENTIONAL LIVER RETRACTOR DEVICE (Device)

CONVENTIONAL LIVER RETRACTOR DEVICE

Active Comparator

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

Intervention: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY (Procedure)

FLEXIBLE LIVER RETRACTOR DEVICE

Experimental

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

Intervention: FLEXIBLE LIVER RETRACTOR DEVICE (Device)

FLEXIBLE LIVER RETRACTOR DEVICE

Experimental

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

Intervention: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY (Procedure)

Outcomes

Primary Outcomes

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

Time Frame: during surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

RODRIGO FEITOSA DE ALBUQUERQUE LIMA BABADOPULOS

MD, GASTRIC SURGEON

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

Study Sites (1)

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