Efficacy Evaluation of the Esophagogastric Junction Exposure Obtained by the Flexible Liver Retractor in Gastroplasty for Obesity
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
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
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
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
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
RODRIGO FEITOSA DE ALBUQUERQUE LIMA BABADOPULOS
MD, GASTRIC SURGEON
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
