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Audit of the EVEREG Incisional Hernia Registry (AUDHIT) (AUDHIT)

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ClinicalTrials.gov Identifier: NCT03899012
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Carles Olona Casas, Hospital Universitari Joan XXIII de Tarragona.

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


Condition or disease Intervention/treatment
Incisional Hernia Procedure: Incisional Hernia Surgery

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Years
Official Title: Validation of the Data Quality of the EVEREG Incisional Hernia Surgery Registry
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia


Intervention Details:
  • Procedure: Incisional Hernia Surgery
    Verification of the accuracy in the collection of 21 selected variables in the Spanish EVEREG Incisional Hernia Surgery Registry


Primary Outcome Measures :
  1. Data accuracy [ Time Frame: 2 Years ]
    Determining the case ascertainment percentage for the Spanish EVEREG Incisional Hernia Surgery Registry



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients not registered previously in the EVEREG registry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899012


Contacts
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Contact: Carles Olona, PhD +34977295824 colona.hj23.ics@gencat.cat

Sponsors and Collaborators
Hospital Universitari Joan XXIII de Tarragona.
Investigators
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Principal Investigator: Carles Olona, PhD Consultant General and Digestive Surgeon

Additional Information:

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Responsible Party: Carles Olona Casas, Consultant General and Digestive Surgeon, Hospital Universitari Joan XXIII de Tarragona.
ClinicalTrials.gov Identifier: NCT03899012     History of Changes
Other Study ID Numbers: AUDHIT
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes