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OpenTrials
Completed

NCT Number: NCT02926885

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nucleo de Pesquisa e Desenvolvimento da Universidade Federal do Ceara

Fortaleza, Ceará, 60430-275, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CONVENTIONAL LIVER RETRACTOR DEVICE

Device

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

FLEXIBLE LIVER RETRACTOR DEVICE

Device

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

Laparoscopic Roux-en-y Gastric Bypass Surgery

Procedure

LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY

Primary outcomes

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

    Time frame: during surgery

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 6, 2016
Registry last updated
Oct 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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