NCT03899012

Brief Summary

Objective: The objective of the study is to verify and validate the data collected in the EVEREG Incisional Hernia Surgery Registry between 2012 and 2018 through an audit process. Methods: An audit of registered cases (Incisional Hernia Patients undergoing surgery) from 2012 to 2018, and a descriptive analysis of these data will be performed Expected results: The study could show that the EVEREG Incisional Hernia Registry is a reliable source of information, valid for carrying out specific and exhaustive analysis that may lead to high quality publications. Relevance: The standardization of the data collection is very important to compare outcomes between different centers. This study will allow us to verify the accuracy of the collected data

Trial Health

87
On Track

Trial Health Score

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

Enrollment
337

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

March 1, 2019

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

1.9 years

First QC Date

March 29, 2019

Last Update Submit

March 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Data accuracy

    Determining the case ascertainment percentage for the Spanish EVEREG Incisional Hernia Surgery Registry

    2 Years

Interventions

Verification of the accuracy in the collection of 21 selected variables in the Spanish EVEREG Incisional Hernia Surgery Registry

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The data of all the patients treated in the Hospitals of Catalonia and included in the EVEREG registry of Hernia Incisional from July 2012 to December 2018 will be compiled and analyzed.

You may qualify if:

  • data of all the patients treated in the Hospitals of Catalonia and included in the EVEREG registry of Hernia Incisional from July 2012 to December 2018

You may not qualify if:

  • Patients not registered previously in the EVEREG registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari de Tarragona Joan XXIII

Tarragona, 43007, Spain

Location

Related Publications (1)

  • Olona C, Pereira-Rodriguez JA, Comas J, Villalobos R, Alonso V, Amador S, Bombuy E, Mitru C, Gimeno M, Lopez-Cano M. Data quality validation of the Spanish Incisional Hernia Surgery Registry (EVEREG): pilot study. Hernia. 2023 Jun;27(3):665-670. doi: 10.1007/s10029-023-02782-3. Epub 2023 Mar 24.

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Carles Olona, PhD

    Consultant General and Digestive Surgeon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant General and Digestive Surgeon

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 2, 2019

Study Start

March 1, 2019

Primary Completion

January 15, 2021

Study Completion

February 15, 2022

Last Updated

March 29, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations