Surgical Treatment of Hydatid Liver Disease | NCT05989516

Studies
Surgical Treatment of Hydatid Liver Disease

NCT05989516

Sponsor

University Hospital for Surgical Diseases St. Naum Ohridsk i- Skopje

Status

Completed

Last Update Posted

Aug 29, 2023Actual

Enrollment

72Actual

Phase

Not provided

Conditions

Hydatid Cyst, Hepatic

Interventions

Not provided

Countries

North Macedonia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

Feb 1, 2022Actual

Completion Date

Mar 1, 2023Actual

First Submitted Date

Aug 4, 2023

First Submission Date that Met QC Criteria

Aug 4, 2023

First Posted Date

Aug 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2023

Last Update Posted Date

Aug 29, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elena Zafirovikj, Dr., University Hospital for Surgical Diseases St. Naum Ohridsk i- SkopjePrincipal Investigator

Lead Sponsor

University Hospital for Surgical Diseases St. Naum Ohridsk i- SkopjeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post operative complications	Listing of complications according to Clavien -Dindo classification	one month

Secondary Outcomes

Measure	Description	Time Frame
Recurrence rate	Recurrence rate of hydatid disease in patients	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hydatid liver disease

Exclusion Criteria:

hydatid disease present outside the liver

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

99 Years

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elena Zafirovikj, MD	UHSD St. Naum Ohridski	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Elena Zafirovikj		Skopje		1000	North Macedonia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004444	Echinococcosis, Hepatic

Ancestor Terms

ID	Term
D004443	Echinococcosis
D002590	Cestode Infections
D006373	Helminthiasis
D010272	Parasitic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided