Biliary Fistulas in Surgery of Liver Echinococcosis

Официальное название

Improvement of Methodological Approaches to Diagnostics and Tactics of Treatment of Biliary Fistulas in Surgery of Liver Echinococcosis

Обзор

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.

Вмешательства

• Процедура Conservative surgical treatment of liver echinococcosis, verification of occult biliary fistulas and their elimination by weaving and using medical cyanoacrylate glue
  In conservative surgical operations for liver echinococcosis, the biliary fistula is identified, onto which a U-shaped suture is applied, after which medical cyanoacrylate glue is applied between the suture stitches to the fibrous capsule in the fistula area and the suture threads are tied.

Первичные конечные точки

• Measuring the incidence of bile leakage after conservative surgical interventions for liver echinococcosis [Срок оценки: 3 months]
• Measuring the time of closure of biliary fistulas in the postoperative period [Срок оценки: 3 months]

Вторичные конечные точки (2)

• Measuring the costs of treating patients with liver echinococcosis [Срок оценки: 3 months]
• Measurement of the quality of life of patients after conservative surgical interventions for liver echinococcosis. [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Узбекистан · 1 центр

• Republican specialized scientific and practical medical center of surgery named after acad — Tashkent

Идентификаторы

NCT: NCT06612229 · 27022024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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