Quality Control of Ventral Hernia Surgery by Prospective Registration

November 27, 2023 updated by: Marc Miserez, Universitaire Ziekenhuizen KU Leuven

Quality Control of Ventral Hernia Surgery in 21 Belgian Hospitals by Prospective Registration in Close Collaboration With the Danish Hernia Database.

Quality Control of ventral hernia surgery in 21 Belgian hospitals by prospective registration in close collaboration with the Danish Hernia Database.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

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

Sampling Method

Non-Probability Sample

Study Population

All adult patients undergoing primary ventral/incisional hernia repair

Description

Inclusion criteria

  • Consecutively all patients with an elective or emergency repair of every ventral/incisional hernia (including parastomal hernia)
  • Male and female
  • 18 years or older
  • Operated of supervised by a participating surgeon (participating in this study is not necessarily by a whole surgical department of one of the 18 participating Belgian hospitals, but by specific surgeons)
  • Elective and emergency surgery
  • Signed informed consent form

Exclusion criteria

  • Younger than 18 years
  • Not operated or supervised by participating surgeon
  • Pregnant at inclusion in the registry
  • No signed informed consent form

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
All consecutive patients with primary ventral or incisional hernia
Procedure: Hernia repair
Primary or mesh repair of primary ventral or incisional hernia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation
Time Frame: through study completion, an average of 2 years
reoperation and readmission rate for (mesh-related) complications or recurrence related) complications or recurrence reoperation and readmission rate for (mesh related) complications or recurrence reoperation and readmission rate for (mesh related) complications or recurrence reoperation and readmission rate for (mesh related) complications or recurrence reoperation and readmission rate for (mesh related) complications or recurrence reoperation and readmission rate for (mesh related) complications or recurrence reoperation and readmission rate for (mesh-related) complications or recurrence
through study completion, an average of 2 years

Collaborators and Investigators

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Belgian Section for Abdominal Wall Surgery, section of the Royal Belgian Society for Surgery

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 (Estimated)

July 1, 2024

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 9, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S62600

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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