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Not yet recruitingNCT04624100Updated Nov 28, 2023

Quality Control of Ventral Hernia Surgery by Prospective Registration

An observational study in Ventral Incisional Hernia, sponsored by Universitaire Ziekenhuizen KU Leuven. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Ventral Incisional Hernia

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03

In context

Incisional Hernia

212 studies on the registry are indexed under Incisional Hernia; 58 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 150 across 75 observational studies indexed under Incisional Hernia.

Browse Incisional Hernia studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Universitaire Ziekenhuizen KU Leuven studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All adult patients undergoing primary ventral/incisional hernia repair

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form

Exclusion criteria

Exclusion criteria

  • Younger than 18 years
  • Not operated or supervised by participating surgeon
  • Pregnant at inclusion in the registry
  • No signed form
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • All consecutive patients with primary ventral or incisional hernia

    Procedure: Hernia repair

Interventions

  • ProcedureHernia repair

    Primary or mesh repair of primary ventral or incisional hernia

06

What researchers measure

Primary outcomes

  1. Reoperation

    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

    Time frame: through study completion, an average of 2 years

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2024; primary completion for Feb 2026, 19 months later.

Of 24 observational studies under Incisional Hernia, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 61. This study's planned 19 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2020
First posted
Nov 10, 2020
StartEst.
Jul 1, 2024
Primary completionEst.
Feb 28, 2026
CompletionEst.
Feb 28, 2026
Last update
Nov 28, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04624100
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Belgian Section for Abdominal Wall Surgery, section of the Royal Belgian Society for Surgery
Responsible party
Marc Miserez (MD PhD, Universitaire Ziekenhuizen KU Leuven) — Principal investigator
First posted
Nov 10, 2020
Start date
Jul 1, 2024 (estimated)
Primary completion
Feb 28, 2026 (estimated)
Completion
Feb 28, 2026 (estimated)
Last update
Nov 28, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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