Trials / Completed
CompletedNCT02926885
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CONVENTIONAL LIVER RETRACTOR DEVICE | LIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING CONVENTIONAL RETRACTOR DEVICE |
| DEVICE | FLEXIBLE LIVER RETRACTOR DEVICE | LIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING FLEXIBLE LIVER RETRACTOR DEVICE |
| PROCEDURE | LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY | LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY |
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2016-07-01
- Completion
- 2016-08-01
- First posted
- 2016-10-06
- Last updated
- 2016-10-07
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT02926885. Inclusion in this directory is not an endorsement.