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临床试验/NCT02926885
NCT02926885已完成不适用

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 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Number of incisions made during laparoscopic surgery using flexible retractor when compared to conventional retractor

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Between 18 - 65 years, both genders, with indication of bariatric surgery according to IFSO criteria.
  • •Agreed to participate and signed informed consent form.

排除标准

  • •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.

研究组 & 干预措施

CONVENTIONAL LIVER RETRACTOR DEVICE

Active Comparator

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

干预措施: 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

干预措施: 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

干预措施: 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

干预措施: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY (Procedure)

结局指标

主要结局

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

时间窗: during surgery

次要结局

未报告次要终点

研究者

发起方
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
申办方类型
Other
责任方
Principal Investigator
主要研究者

RODRIGO FEITOSA DE ALBUQUERQUE LIMA BABADOPULOS

MD, GASTRIC SURGEON

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

研究点 (1)

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