NCT05989516

Brief Summary

The goal of this observational study is to show that cyst extraction with pericyst reduction and omentopexy is a suitable treatment for liver hydatid disease caused by E.Granulossus with a low rate of complication and recurrence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 4, 2023

Last Update Submit

August 25, 2023

Conditions

Hydatid Cyst, Hepatic

Outcome Measures

Primary Outcomes (1)

  • Post operative complications

    Listing of complications according to Clavien -Dindo classification

    one month

Secondary Outcomes (1)

  • Recurrence rate

    5 years

Eligibility Criteria

Age16 Years - 99 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We have analyzed 72 patients diagnosed with liver hydatid disease for a period of 10 years from January 2006 until January 2017 treated surgically by cyst extraction, pericystectomy, and omentopexy.

You may qualify if:

  • hydatid liver disease

You may not qualify if:

  • hydatid disease present outside the liver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elena Zafirovikj

Skopje, 1000, North Macedonia

Location

MeSH Terms

Conditions

Echinococcosis, Hepatic

Condition Hierarchy (Ancestors)

EchinococcosisCestode InfectionsHelminthiasisParasitic DiseasesInfectionsLiver Diseases, ParasiticLiver DiseasesDigestive System Diseases

Study Officials

  • Elena Zafirovikj, MD

    UHSD St. Naum Ohridski

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

February 1, 2021

Primary Completion

February 1, 2022

Study Completion

March 1, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Locations

NO(1)