NCT05113550

Brief Summary

Cystic echinococcosis is a clinically complex chronic parasitic disease and a major socioeconomic problem in endemic areas. The safety of liver resection in elderly patients is often debated among medical professionals. The investigators analyzed the postoperative morbidity and mortality rates of elderly patients who underwent surgery at our unit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
279

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

January 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
Last Updated

November 16, 2021

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

October 28, 2021

Last Update Submit

November 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Morbidity

    Patients with postoperative morbidity according to the Clavien-Dindo score 19, "severe complication" (Clavien-Dindo ≥ IIIa) and postoperative mortality

    90 days

Study Arms (2)

Young group

patients \< 70 years of age

Other: Surgical remove

Elderly

Patients ≥ 70 years of age)

Other: Surgical remove

Interventions

liver hydatid cyst (LHC) treated by total or partial pericystectomy

ElderlyYoung group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with liver hydatidosis carried out at our Hepato-Pancreato-Biliary Surgery Unit

You may qualify if:

  • liver hydatid cyst (LHC)
  • pathological diagnosis after surgery
  • LHC treated by total or partial pericystectomy

You may not qualify if:

  • emergency surgery and simple drainage of cyst

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidad de Extremadura- Facultad de Medicina

Badajoz, 06080, Spain

Location

Gerardo Blanco-Fernández

Badajoz, 08080, Spain

Location

Related Publications (5)

  • Mihmanli M, Idiz UO, Kaya C, Demir U, Bostanci O, Omeroglu S, Bozkurt E. Current status of diagnosis and treatment of hepatic echinococcosis. World J Hepatol. 2016 Oct 8;8(28):1169-1181. doi: 10.4254/wjh.v8.i28.1169.

    PMID: 27729953BACKGROUND
  • Adamina M, Guller U, Weber WP, Oertli D. Propensity scores and the surgeon. Br J Surg. 2006 Apr;93(4):389-94. doi: 10.1002/bjs.5265.

    PMID: 16400708BACKGROUND
  • Jaen-Torrejimeno I, Lopez-Guerra D, Prada-Villaverde A, Blanco-Fernandez G. Pattern of Relapse in Hepatic Hydatidosis: Analysis of 238 Cases in a Single Hospital. J Gastrointest Surg. 2020 Feb;24(2):361-367. doi: 10.1007/s11605-019-04163-7. Epub 2019 Feb 26.

    PMID: 30809783BACKGROUND
  • Jaen-Torrejimeno I, Latorre-Fragua R, Lopez-Guerra D, Rojas-Holguin A, Manuel-Vazquez A, Blanco-Fernandez G, Ramia JM. Jaundice as a clinical presentation in liver hydatidosis increases the risk of postoperative biliary fistula. Langenbecks Arch Surg. 2021 Jun;406(4):1139-1147. doi: 10.1007/s00423-020-02070-z. Epub 2021 Jan 2.

    PMID: 33389115BACKGROUND
  • Muhtarov M, Rainova I, Tamarozzi F. Treatment of Hepatic Cystic Echinococcosis in Patients from the Southeastern Rhodope Region of Bulgaria in 2004-2013: Comparison of Current Practices with Expert Recommendations. Am J Trop Med Hyg. 2016 Apr;94(4):900-5. doi: 10.4269/ajtmh.15-0620. Epub 2016 Feb 1.

MeSH Terms

Conditions

Echinococcosis

Condition Hierarchy (Ancestors)

Cestode InfectionsHelminthiasisParasitic DiseasesInfections

Study Officials

  • Gerardo Blanco-Fernández, MD, PhD

    University of Extremadura

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 9, 2021

Study Start

January 1, 2021

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

November 16, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations