ClinicalTrials.gg
CompletedNCT07793448Updated Aug 28, 2026

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

An interventional study of omentoplasty and External Tube Drainage in Hepatic Cystic Echinococcosis, sponsored by Ataturk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Ataturk University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 5 months after the study started (first participant enrolled Mar 2020, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Hepatic Cystic Echinococcosis

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Keywords

  • Cystic Echinococcosis, Hydatid Cyst, Liver, Omentoplasty, Tube Drainage, Residual Cavity, Conservative Surgery, Biliary Fistula
03

In context

Echinococcosis

25 studies on the registry are indexed under Echinococcosis; 4 are open to participants now.

Browse Echinococcosis studies →

Lead sponsor

Ataturk University is the lead sponsor of 458 studies on the registry; 124 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
  • ≤III.

Exclusion criteria

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.
  • .
  • Pregnancy.
  • >III.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Omentoplasty Group

    Participants underwent conservative surgery for complicated hepatic cystic echinococcosis followed by omentoplasty for residual cavity management.

    Procedure: omentoplasty

  • Active comparator
    Tube Drainage Group

    Participants underwent conservative surgery for complicated hepatic cystic echinococcosis followed by external tube drainage for residual cavity management.

    Procedure: External Tube Drainage

Interventions

  • Procedureomentoplasty

    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.

  • ProcedureExternal Tube Drainage

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

06

What researchers measure

Primary outcomes

  1. Postoperative Residual Cavity-Related Complications

    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.

    Time frame: Up to 30 days after surgery

Secondary outcomes

  1. Postoperative Bile Leakage

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

    Time frame: Up to 30 days after surgery

  2. Surgical Site Infection

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

    Time frame: Up to 30 days after surgery

  3. Overall Postoperative Complications

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

    Time frame: Up to 30 days after surgery

  4. Operative Time

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

    Time frame: During surgery

  5. Recurrence of Hepatic Cystic Echinococcosis

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

    Time frame: Up to at least 60 months after surgery

07

Study locations

1 site
  • Atatürk University Faculty of Medicine
    Erzurum, Erzurum 25240, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be publicly shared due to patient confidentiality and ethical considerations. Aggregate study results will be reported in the planned scientific publication.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2020 to primary completion in Jun 2021, 15 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2026
First posted
Aug 28, 2026
StartActual
Mar 10, 2020
Primary completionActual
Jun 10, 2021
CompletionActual
Mar 10, 2026
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07793448
Lead sponsor
Ataturk University
Responsible party
Bilal Aydin (MD, Ataturk University) — Principal investigator
First posted
Aug 28, 2026
Start date
Mar 10, 2020
Primary completion
Jun 10, 2021
Completion
Mar 10, 2026
Last update
Aug 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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