Common Bile Duct Pressure After Intraoperative Instrumentation in Patients With Uncomplicated Choledocholithiasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 主要终点
- First week control common bile duct pressure
研究概览
简要总结
A study that included patients of any gender between 15 and 70 years, with the diagnosis of choledocholithiasis who required a cholecystectomy with an exploration of bile ducts. Conventional cholecystectomy was performed and a T-tube was inserted in the common bile duct (CBD) to measure the intraluminal pressure immediately after the procedure, and weekly thereafter, with a 6-week follow-up. A control T-tube radiological study was performed at six weeks to exclude residual stones.
详细描述
A clinical, controlled, prospective, longitudinal, descriptive, observational and double-blinded study was designed. Patients of any gender between 15 and 70 years, with a diagnosis of choledocholithiasis, and who required a cholecystectomy with an exploration of bile ducts were included. Conventional cholecystectomy was performed and perioperative T-tube CBD pressure was registered immediately after the procedure, and weekly thereafter, with a 6-week follow-up.
Control T-tube cholangiogram was performed at six weeks to exclude residual stones. Data was analyzed with T-test for parametric values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Choledocholithiasis -
排除标准
- •To not complete the follow-up period
研究组 & 干预措施
Patients with Choledocholithiasis
Patients were managed by elective open cholecystectomy and operative exploration of the common bile duct.
干预措施: Cholecystectomy and common bile duct exploration (Procedure)
结局指标
主要结局
First week control common bile duct pressure
时间窗: First week
CBD manometry was obtained one week after cholecystectomy
Second week control common bile duct pressure
时间窗: Second week
CBD manometry was obtained two weeks after cholecystectomy
Basal common bile duct (CBD) pressure
时间窗: Intraoperative
Basal CBD manometry was obtained immediately after cholecystectomy
Third week control common bile duct pressure
时间窗: Third week
CBD manometry was obtained three weeks after cholecystectomy
Fifth week control common bile duct pressure
时间窗: Fifth week
CBD manometry was obtained five weeks after cholecystectomy
Fourth week control common bile duct pressure
时间窗: Fourth week
CBD manometry was obtained four weeks after cholecystectomy
Sixth week control common bile duct pressure
时间窗: Sixth week
CBD manometry was obtained six weeks after cholecystectomy
次要结局
未报告次要终点
研究者
Carlos R. Cervantes Sanchez, MD, MSc
General Surgery Service
Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo