Surgical Treatment of Liver Hydatid Cyst (SURGHIDA) (SURGHIDA)

June 14, 2022 updated by: Gerardo Blanco-Fernández, Universidad de Extremadura

Outcome After Surgical Treatment of Liver Hydatid Cyst

The aim was to analyses the incidence and the independent factors associated with Textbook Outcome following surgical treatment of liver hydatid cysts (LHC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Textbook outcome (TO) is a composite measure to determine the ideal postoperative period and to assess the quality of surgical care. The aim was to analyses the incidence and the independent factors associated with TO following surgical treatment of liver hydatid cysts (LHC).

The investigators conducted a retrospective cohort study of patients operated on for hepatic hydatidosis between January 2006 to December 2021. TO occurred when all the following criteria were fulfilled: no mortality within 90 days, no major complications within 90 days, no reintervention within 90 days and no prolonged hospital stay. Univariable and multivariable analyses were performed to identify factors associated with TO.

Study Type

Observational

Enrollment (Actual)

296

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 hydatid cyst (LHC) diagnosed by preoperative computed tomography (CT) or magnetic resonance imaging (MRI) and pathological diagnosis after surgery, treated by total or partial pericystectomy

Description

Inclusion Criteria:

  • Patients with liver hydatid cyst 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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical group
Patients operated on liver hydatidic cyst
Procedure: Surgical resection
Surgical treatment of hepatic hydatidic cyst

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 90 days
no mortality within 90 days
90 days
Morbidity
Time Frame: 90 days
no major complications within 90 days
90 days
Re-admission
Time Frame: 90 days
no re-admissions within 90 days
90 days

Collaborators and Investigators

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

Sponsor

Universidad de Extremadura

Collaborators

Complejo Hospitalario Universitario de Badajoz

Investigators

  • Study Director: 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, 2006

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

May 30, 2022

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

June 14, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 14, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UE-CHUB-001-2022

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.

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