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