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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02926885

Enrollment

100

Registered

2016-10-06

Start date

2015-08-31

Completion date

2016-08-31

Last updated

2016-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

liver, laparoscopy, Bariatric Surgery, Esophagogastric Junction, obesity

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.

Interventions

DEVICECONVENTIONAL LIVER RETRACTOR DEVICE

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

DEVICEFLEXIBLE LIVER RETRACTOR DEVICE

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

PROCEDURELAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY

LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026