NCT04624100

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

November 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
3.6 years until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

1.7 years

First QC Date

November 4, 2020

Last Update Submit

November 27, 2023

Conditions

Ventral Incisional Hernia

Outcome Measures

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

    through study completion, an average of 2 years

Study Arms (1)

All consecutive patients with primary ventral or incisional hernia

Procedure: Hernia repair

Interventions

Hernia repairPROCEDURE

Primary or mesh repair of primary ventral or incisional hernia

All consecutive patients with primary ventral or incisional hernia

Eligibility Criteria

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

All adult patients undergoing primary ventral/incisional hernia repair

You may qualify if:

  • Consecutively all patients with an elective or emergency repair of every ventral/incisional hernia (including parastomal hernia)
  • Male and female
  • 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

You may not qualify if:

  • Younger than 18 years
  • Not operated or supervised by participating surgeon
  • No signed informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Herniorrhaphy

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 10, 2020

Study Start

July 1, 2024

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

November 28, 2023

Record last verified: 2023-11