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临床试验/NCT02658643
NCT02658643已完成不适用

Randomized Controlled Study to Determine the Difference in Time and Complication Rate for Biliodigestive Anastomosis by Continuous Versus Interrupted Suture Technique

Technische Universität Dresden1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年1月20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
入组人数
80
试验地点
1
主要终点
Time to complete the biliodigestive anastomosis

研究概览

简要总结

The aim of this prospective randomized controlled study is to determine the benefit-risk ratio (success rate, complication rate, tolerance) for patients with biliodigestive anastomosis by either continuous or interrupted suture.

详细描述

The aim of this prospective randomized controlled study is to determine the benefit-risk ratio (success rate, complication rate, tolerance) for patients with biliodigestive anastomosis by either continuous or interrupted suture. A biliodigestive anastomosis is a surgical connection between the common bile duct (ductus choledochus) and the digestive tract to prevent interference of bile flow. Indications for a biliodigestive anastomosis include total or partial resection of the pancreas and duodenum (PPPD, Whipple procedure) for pancreatic tumors, tumors of the biliary tract or duodenum, and biliary tract reconstructions during liver transplantation or advanced liver resections. Furthermore a biliodigestive anastomosis can be required to manage the injury of the biliary tract and infectious and traumatic structures of the biliary tract. Biliodigestive anastomoses can be performed by continuous or interrupted suture. The aim of this study is to determine the difference between continuous and interrupted suture for biliodigestive anastomoses, as advantages and disadvantages of each technique have not been determined. Only patients receiving their first biliodigestive anastomosis will be included.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • •Patients over 18 years of age
  • •Scheduled for elective BDA procedure
  • •Primary BDA procedure
  • •Diameter of DHC > 7mm
  • •Written consent

排除标准

  • •Previous BDA procedure
  • •Impaired mental state or language problems
  • •Lacking compliance
  • •Emergency procedure

研究组 & 干预措施

Continuous suture technique

Experimental

The BDA is performed as continuous suture with two separate all-layer suture for the behind - and front-wall of the anastomosis

干预措施: Continuous suture technique (Procedure)

Interrupted suture technique

Active Comparator

The BDA is performed as interrupted suture with two separate all-layer suture for the behind - and front-wall of the anastomosis

干预措施: Interrupted suture technique (Procedure)

结局指标

主要结局

Time to complete the biliodigestive anastomosis

时间窗: 30 minutes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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