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

NCT07793448 | Completed

• 1 other identifier: ATAUNI-HCE-OPTD-2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatic Cystic Echinococcosis

Keywords

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

Outcome Measures

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.

  Up to 30 days after surgery

Secondary Outcomes (5)

• Postoperative Bile Leakage

  Up to 30 days after surgery

• Surgical Site Infection

  Up to 30 days after surgery

• Overall Postoperative Complications

  Up to 30 days after surgery

• Operative Time

  During surgery

• Recurrence of Hepatic Cystic Echinococcosis

  Up to at least 60 months after surgery

Study Arms (2)

Omentoplasty Group

EXPERIMENTAL

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

Procedure: omentoplasty

Tube Drainage Group

ACTIVE COMPARATOR

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

Procedure: External Tube Drainage

Interventions

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.

Omentoplasty Group

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.

Tube Drainage Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University Faculty of Medicine

Erzurum, Erzurum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Echinococcosis; Biliary Fistula

Condition Hierarchy (Ancestors)

Cestode Infections; Helminthiasis; Parasitic Diseases; Infections; Digestive System Fistula; Digestive System Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants were assigned to two parallel groups undergoing either omentoplasty or tube drainage for residual cavity management following conservative surgery for complicated hepatic cystic echinococcosis.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 28, 2026
• Study Start: March 10, 2020
• Primary Completion: June 10, 2021
• Study Completion: March 10, 2026
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)