Re-use of Ambu aScope During Exploration of the Common Bile Duct for Stones in Low-Resource Settings- a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Feasibility of re-use of aScope during exploration of CBD for stone
研究概览
简要总结
Various methods confirm stone clearance during surgical exploration of bile duct, but choledochoscopy is considered the most effective. However, choledochoscopes are expensive and often unavailable in low-resource settings. The Ambu aScope, a disposable flexible video-bronchoscope used in anesthesia, has been successfully tried as a cheaper alternative for CBD (Common Bile Duct) exploration in other countries. In Nepal, where affordability is a concern, reuse of properly disinfected Ambu aScopes may be justifiable if proven safe. Existing studies are limited and small in scale; this study is the first from Nepal to evaluate the reuse of Ambu aScope for choledochoscopy.
This retrospective observational study will include all patients with CBD stones who underwent CBD exploration for stone using Ambu aScope in Department of Surgery of BPKIHS, Dharan between January 2022 and December 2024.
Case record files of all patients who underwent CBD exploration using aScope as a Choledochoscope over last 3 years period will be obtained from medical record section and computer database of our department. All relevant information including patient demographics, indication for a CBD exploration, operative approach and procedure performed, intraoperative achievement of acceptable view of extrahepatic biliary tree using an aScope, intraoperative stone clearance on direct visualization of biliary tree and confirmation on postoperative T-tube cholangiogram or imaging on 10-14th postoperative day and intra/post-operative complications associated with the use of the aScope will be entered in a preformed proforma. In case of some missing information in medical case report sheet or computer database of our department, patient will be called directly on the contact number provided in admission sheet and through the telephonic conversation, the concerned queries will be cleared. Data will be entered in Microsoft Excel and analyzed by SPSS version 29.0.1.0. Qualitative data were described using numbers and percentages. Quantitative data will be described using range (minimum and maximum), mean, standard deviation, and median.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients with CBD stones who underwent CBD exploration for stone using the Ambu aScope in Department of Surgery of BPKIHS, Dharan between January 2022 and December 2024
排除标准
- •Single stone of <1cm, Patient not fit for general anesthesia, Pregnancy
结局指标
主要结局
Feasibility of re-use of aScope during exploration of CBD for stone
时间窗: intraoperative and early post operative upto 2 weeks
Success rate (in percentage) of achieving acceptable view of extrahepatic biliary tree form the 2nd generation biliary radicles proximally to the ampulla of Vater distally with Ambu aScope. Stone clearance rate (in percentage) with the use of ambu aScope Occurrence (in terms of percentage) of complications (such as Injury to biliary tree, Cholangitis related with reuse of the aScope)
次要结局
- Demographic distribution of patients with CBD stone(perioperative period upto 2weeks post-surgery)
研究者
Abhijeet Kumar
Associate Professor
B.P. Koirala Institute of Health Sciences
