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

N

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

Status

Completed

Conditions

Obesity

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

CONVENTIONAL LIVER RETRACTOR DEVICE
Active Comparator group
Description:
USE OF CONVENTIONAL LIVER RETRACTOR FOR THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
Treatment:
Procedure: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
Device: CONVENTIONAL LIVER RETRACTOR DEVICE
FLEXIBLE LIVER RETRACTOR DEVICE
Experimental group
Description:
USE OF THE FLEXIBLE LIVER RETRACTOR FOR THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
Treatment:
Device: FLEXIBLE LIVER RETRACTOR DEVICE
Procedure: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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