Improvement of Methodological Approaches to Diagnostics and Tactics of Treatment of Biliary Fistulas in Surgery of Liver Echinococcosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Measuring the incidence of bile leakage after conservative surgical interventions for liver echinococcosis
研究概览
简要总结
The objective of the study is to improving the results of surgical treatment of liver echinococcosis complicated by biliary fistula by optimizing diagnostic approaches to early verification of this complication and improving the tactical and technical aspects of its elimination.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age under 18 years;
- •Informed consent for inclusion in the study;
- •The presence of liver echinococcosis, for which conservative surgical treatment will be performed;
- •The presence of the entire spectrum of necessary preoperative diagnostic measures;
- •A full description of all stages of surgical intervention, indicating the type of intervention (open or laparoscopic surgery, location and size of the echinococcal cyst in the liver, type of antiparasitic treatment, presence or absence of a biliary fistula in the residual cavity, actions taken in relation to the fistula, the option of eliminating the residual cavity and drainage;
- •Availability of objective data on the characteristics of the postoperative course, including dynamic indicators of the patient's condition, temperature, amount and nature of discharge through the drainage, the time of drainage removal, the type of complications (if any) and the method of their treatment, the duration of the hospital period, data on the characteristics of the posthospital period up to 3 months of observation;
- •Absence of concomitant pathology that may affect the outcome of the surgery.
排除标准
- •Age under 18 years;
- •Refusal to participate in the study;
- •Extrahepatic echinococcosis without liver damage;
- •Absence of the full range of preoperative diagnostic data;
- •Difficulties with objective analysis of the features of the performed surgical treatment;
- •Incomplete data on monitoring the postoperative hospital and remote (up to 3 months) period;
- •The presence of concomitant pathology that may affect the outcome of the operation.
结局指标
主要结局
Measuring the incidence of bile leakage after conservative surgical interventions for liver echinococcosis
时间窗: 3 months
assessing the effectiveness of the method for eliminating biliary fistulas in the fibrous capsule during organ-preserving surgeries for liver echinococcosis, characterized by creating a two-level strengthening of the fistula area by applying U-shaped sutures and a cyanoacrylate adhesive composition
Measuring the time of closure of biliary fistulas in the postoperative period
时间窗: 3 months
In the group of patients with the development of biliary fistulas after surgery, the time of their closure in days will be studied
次要结局
- Measuring the costs of treating patients with liver echinococcosis(3 months)
- Measurement of the quality of life of patients after conservative surgical interventions for liver echinococcosis.(3 months)
研究者
Azam Babadjanov
Professor
Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov