Surgical Treatment of Hepatic Hydatidosis in Elderly Patients (ELDHIDA)

November 8, 2021 updated by: Gerardo Blanco-Fernández, Universidad de Extremadura
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Retrospective observational study from prospective database focused on liver hydatidosis carried out at our Hepato-Pancreato-Biliary Surgery Unit. The study period spanned from January 2006 to October 2020. The study was approved by the Research Ethics Committee of our hospital. An informed consent from the patient was not required since the study was retrospective and observational, and entailed no risk. Seventy years of age was the cutoff age to consider patients as elderly.

Inclusion criteria of patients: liver hydatid cyst (LHC) diagnosed by preoperative computed tomography (CT) or magnetic resonance imaging (MRI) and pathological diagnosis after surgery, and LHC treated by total or partial pericystectomy.

Exclusion criteria of patients: emergency surgery and simple drainage of cyst.

Study Type

Observational

Enrollment (Actual)

279

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badajoz, Spain, 06080
        • Universidad de Extremadura- Facultad de Medicina
      • Badajoz, Spain, 08080
        • Gerardo Blanco-Fernández

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • emergency surgery and simple drainage of cyst

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Young group
patients < 70 years of age
Other: Surgical remove
liver hydatid cyst (LHC) treated by total or partial pericystectomy
Elderly
Patients ≥ 70 years of age)
Other: Surgical remove
liver hydatid cyst (LHC) treated by total or partial pericystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: 90 days
Patients with postoperative morbidity according to the Clavien-Dindo score 19, "severe complication" (Clavien-Dindo ≥ IIIa) and postoperative mortality
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Extremadura

Investigators

  • Principal Investigator: Gerardo Blanco-Fernández, MD, PhD, University of Extremadura

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (Actual)

November 9, 2021

Study Record Updates

Last Update Posted (Actual)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUB-2021-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystic Echinococcosis

Clinical Trials on Surgical remove

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe