NCT05420155

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
296

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

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, 2006

Completed
16 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

16 years

First QC Date

June 10, 2022

Last Update Submit

June 14, 2022

Conditions

Echinococcosis, Hepatic

Outcome Measures

Primary Outcomes (3)

  • Mortality

    no mortality within 90 days

    90 days

  • Morbidity

    no major complications within 90 days

    90 days

  • Re-admission

    no re-admissions within 90 days

    90 days

Study Arms (1)

Surgical group

Patients operated on liver hydatidic cyst

Procedure: Surgical resection

Interventions

Surgical resectionPROCEDURE

Surgical treatment of hepatic hydatidic cyst

Surgical group

Eligibility Criteria

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

You may qualify if:

  • Patients with liver hydatid cyst 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

Related Publications (5)

  • Manterola C, Otzen T, Urrutia S; MINCIR Group (Methodology and Research in Surgery). Risk factors of postoperative morbidity in patients with uncomplicated liver hydatid cyst. Int J Surg. 2014;12(7):695-9. doi: 10.1016/j.ijsu.2014.05.063. Epub 2014 May 21.

    PMID: 24859488BACKGROUND

  • van Roessel S, Mackay TM, van Dieren S, van der Schelling GP, Nieuwenhuijs VB, Bosscha K, van der Harst E, van Dam RM, Liem MSL, Festen S, Stommel MWJ, Roos D, Wit F, Molenaar IQ, de Meijer VE, Kazemier G, de Hingh IHJT, van Santvoort HC, Bonsing BA, Busch OR, Groot Koerkamp B, Besselink MG; Dutch Pancreatic Cancer Group. Textbook Outcome: Nationwide Analysis of a Novel Quality Measure in Pancreatic Surgery. Ann Surg. 2020 Jan;271(1):155-162. doi: 10.1097/SLA.0000000000003451.

    PMID: 31274651BACKGROUND

  • de la Plaza Llamas R, Ramia Angel JM, Bellon JM, Arteaga Peralta V, Garcia Amador C, Lopez Marcano AJ, Medina Velasco AA, Gonzalez Sierra B, Manuel Vazquez A. Clinical Validation of the Comprehensive Complication Index as a Measure of Postoperative Morbidity at a Surgical Department: A Prospective Study. Ann Surg. 2018 Nov;268(5):838-844. doi: 10.1097/SLA.0000000000002839.

    PMID: 30303875BACKGROUND

  • Mehta R, Tsilimigras DI, Pawlik TM. Assessment of Magnet status and Textbook Outcomes among medicare beneficiaries undergoing hepato-pancreatic surgery for cancer. J Surg Oncol. 2021 Sep;124(3):334-342. doi: 10.1002/jso.26521. Epub 2021 May 7.

    PMID: 33961716BACKGROUND

  • 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

MeSH Terms

Conditions

Echinococcosis, Hepatic

Condition Hierarchy (Ancestors)

EchinococcosisCestode InfectionsHelminthiasisParasitic DiseasesInfectionsLiver Diseases, ParasiticLiver DiseasesDigestive System Diseases

Study Officials

  • Gerardo Blanco-Fernández, MD, PhD

    University of Extremadura

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 10, 2022

First Posted

June 15, 2022

Study Start

January 1, 2006

Primary Completion

December 31, 2021

Study Completion

May 30, 2022

Last Updated

June 15, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share