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临床试验/NCT05243225
NCT05243225尚未招募不适用

Laparoscopic Versus Open Surgical Management of Post Cholecystectomy Bile Duct Injury

Assiut University0 个研究点目标入组 40 人开始时间: 2023年6月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
Comparison between outcomes of laparoscopic and open surgical management of post cholecystectomy bile duct injury.

研究概览

简要总结

Comparison between laparoscopic and open surgical management of post cholecystectomy bile duct injury.

详细描述

Bile duct injury (BDI) post cholecystectomy is an iatrogenic catastrophe associated with significant morbidity , mortality and poor quality of life this is due to the large number of cholecystectomies per year all over the world. Cholecystectomy whether open or laparoscopic is done in large number about 750,000 annually in USA, the incidence of BDI post cholecystectomy is about 0.1-0.2% in open cholecystectomy and 0.4-0.6% in laparoscopic cholecystectomy although the percentage appears small but it still large number about 2100 patients per year. The two most frequent scenarios of BDI may be occurrence of bile leak or bile duct obstruction. Early recognition of iatrogenic bile duct injury is essential to prevent major morbidity by imaging techniques, such as Ultrasound and CT which are extremely valuable during the initial evaluation but MRCP remains the gold standard for diagnosis. ERCP can confirm the presence of biliary injury and provides a means for definitive management. The main aim of surgical treatment is the reconstruction of proper flow of bile to the alimentary tract. Repair of such injuries still remains a challenge due to the variety of size of injury, site of injury if proximal or distal, the severity of injury and the time of presentation after the injury. Repair of such BDI may be done by laparoscopy or by open surgery which still a matter of debate. There are many described techniques should be done by specialized hepatobiliary surgeon from simple repair, repair over T-tube up to hepaticojejunostomy. Despite widespread advances in laparoscopic surgery, laparoscopic repair of post-cholecystectomy bile duct injury (BDI) has rarely been reported related mainly to technical difficulty.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with post cholecystectomy bile duct injuries admitted to surgery department in Asyut University Hospitals and El-Rajhi hospital at the period of the study.
  • Patients fit for surgery.
  • Patients informed consent for study.
  • Patients with signs and symptoms due to Bile duct injury like abdominal pain, jaundice and high liver function parameters

排除标准

  • Unfit cases for laparoscopic surgery.
  • Unfit patients for open surgery.
  • Patients refuse consent to participate in the study.
  • Patients who had previous repair.
  • Patients who present with abdominal sepsis.

结局指标

主要结局

Comparison between outcomes of laparoscopic and open surgical management of post cholecystectomy bile duct injury.

时间窗: Baseline

Analysis of efficacy of repair in laparoscopic and open surgical management of post cholecystectomy bile duct injury

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amir William Samir Fahmy

General Surgery Resident: Amir William Samir Fahmy

Assiut University

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