Biliary Fistulas in Surgery of Liver Echinococcosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRepublican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Age under 18 years;

Refusal to participate in the study;

Extrahepatic echinococcosis without liver damage;

Absence of the full range of preoperative diagnostic data;

Trial design

Design model

Single group

Treatments tested in this trial

  • Conservative surgical treatment of liver echinococcosis, verification of occult biliary fistulas and their elimination by weaving and using medical cyanoacrylate glue

    Procedure/Surgery

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: operation for liver echinococcosis complicated by a biliary fistulaOther 1 intervention

Trial outcomes

Primary outcomes

1

Measuring the incidence of bile leakage after conservative surgical interventions for liver echinococcosis

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

Time frame
3 months
2

Measuring the time of closure of biliary fistulas in the postoperative period

In the group of patients with the development of biliary fistulas after surgery, the time of their closure in days will be studied

Time frame
3 months

Secondary outcomes

1

Measuring the costs of treating patients with liver echinococcosis

Economic costs will be assessed for patients with liver echinococcosis who undergo conservative surgical interventions, taking into account the absence or development of bile leakage in the postoperative period

Time frame
3 months
2

Measurement of the quality of life of patients after conservative surgical interventions for liver echinococcosis.

The quality of life will be analyzed using the SF-36 (The 36-Item Short Form Survey) questionnaire in patients after conservative surgical interventions, taking into account the absence or development of bile leakage in the postoperative period. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life. Scores for the various domains are transformed and combined using a scoring key to obtain a total score indicating a range from low to high quality of life (from 0 to 100 points). Scores for two components, the physical component and the mental component, can also be calculated.

Time frame
3 months

Other outcomes

Sponsors and contacts

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