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NCT Number: NCT07793448

Omentoplasty Versus Tube Drainage for Residual Cavity Management in Complicated Hepatic Cystic Echinococcosis

This prospective comparative study evaluated two surgical techniques for residual cavity management following conservative surgery for complicated hepatic cystic echinococcosis. Patients undergoing surgery were managed with either omentoplasty or tube drainage. The study aimed to compare postoperative outcomes between the two techniques, with particular emphasis on postoperative complications and residual cavity-related complications. Long-term follow-up was also performed to assess recurrence and other clinical outcomes.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University Faculty of Medicine

Erzurum, 25240, Turkey (Türkiye)

About this study

Cystic echinococcosis of the liver may be associated with complications such as biliary communication, infection, rupture, cholangitis, and involvement of adjacent structures. Following conservative surgical treatment, appropriate management of the residual hepatic cavity remains an important component of surgical care.

This prospective, single-center comparative study was conducted at Atatürk University Faculty of Medicine and included adult patients undergoing conservative surgery for complicated hepatic cystic echinococcosis. Eligible patients were allocated to residual cavity management with either omentoplasty or tube drainage according to a predetermined alternating allocation strategy.

The study was designed to compare the clinical outcomes of these two residual cavity management techniques. Postoperative outcomes included overall postoperative complications, surgical site infection, biliary fistula, and residual cavity-related complications. Operative characteristics and other relevant perioperative outcomes were also evaluated.

All surgical procedures were performed by the same surgical team using a standardized perioperative approach. Patients received albendazole treatment according to the institutional treatment protocol. Following surgery, patients underwent clinical and radiological follow-up using ultrasonography and/or computed tomography as clinically appropriate. Long-term follow-up was used to evaluate recurrence and other relevant clinical outcomes.

The primary objective of the study was to determine whether the method used for residual cavity management was associated with differences in postoperative outcomes after conservative surgery for complicated hepatic cystic echinococcosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-80 years.
  • Complicated hepatic cystic echinococcosis requiring surgical treatment.
  • Cyst diameter ≥8 cm.
  • Cysts located in hepatic segments IV, V, VI, VII, or VIII.
  • WHO-IWGE CE2 or CE3b cyst stage.
  • Presence of at least one complication or high-risk feature, including rupture, adjacent organ involvement, cholangitis, biliary communication, or cyst infection.
  • ASA physical status ≤III.

Exclusion criteria

  • WHO-IWGE CE1 or CE3a cyst stage.
  • Cysts located in hepatic segments I, II, or III.
  • Extensive multiple hepatic cysts.
  • Previous surgery for hepatic cystic echinococcosis.
  • Malignancy.
  • Pregnancy.
  • ASA physical status >III.

Treatment and study plan

omentoplasty

Procedure

After conservative surgery for complicated hepatic cystic echinococcosis, the residual cavity was obliterated using a pedicled omental flap (omentoplasty) to reduce dead space and cavity-related complications.

External Tube Drainage

Procedure

After conservative surgery for complicated hepatic cystic echinococcosis, an external tube drain was placed into the residual cavity for postoperative drainage and monitoring.

Primary outcomes

  1. Postoperative Residual Cavity-Related Complications

    Time frame: Up to 30 days after surgery

    Incidence of postoperative complications related to the residual hepatic cyst cavity, including residual cavity infection, abscess formation, or other cavity-related complications, compared between the omentoplasty and tube drainage groups.

Secondary outcomes

  1. Postoperative Bile Leakage

    Time frame: Up to 30 days after surgery

    Incidence of postoperative bile leakage, defined as clinically evident biliary drainage after surgery, compared between the omentoplasty and tube drainage groups.

  2. Surgical Site Infection

    Time frame: Up to 30 days after surgery

    Incidence of postoperative surgical site infection compared between the omentoplasty and tube drainage groups.

  3. Overall Postoperative Complications

    Time frame: Up to 30 days after surgery

    Incidence of overall postoperative complications compared between the omentoplasty and tube drainage groups

  4. Operative Time

    Time frame: During surgery

    Duration of surgery from skin incision to completion of skin closure, compared between the omentoplasty and tube drainage groups

  5. Recurrence of Hepatic Cystic Echinococcosis

    Time frame: Up to at least 60 months after surgery

    Comparison of the incidence of hepatic cystic echinococcosis recurrence between the omentoplasty and tube drainage groups during long-term follow-up

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Omentoplasty Versus Tube Drainage for Residual Cavity Management After Conservative Surgery for Complicated Hepatic Cystic Echinococcosis: A Prospective Comparative Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2026
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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