NCT06783036

Brief Summary

Nationwide, registry based cohort studies on all complications requiring surgery following primary ventral hernia repair

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
7,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

February 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

9 months

First QC Date

January 14, 2025

Last Update Submit

January 21, 2025

Conditions

Umbilical HerniaEpigastric Hernia

Outcome Measures

Primary Outcomes (1)

  • Operation for hernia recurrence

    Until december 31, 2023

Secondary Outcomes (1)

  • Operation for non-recurrence complication

    Until december 31, 2023

Study Arms (4)

Emergency umbilical hernia repair

no study intervention

Elective umbilical hernia repair

no study intervention

Emergency epigastric hernia repair

no study intervention

Elective epigastric hernia repair

no study intervention

Eligibility Criteria

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

Nationwide population of patients registered in the Danish Ventral Hernia Database

You may qualify if:

  • Operation for primary ventral hernia repair registered in Danish Ventral Hernia Database
  • Known body mass index and smoking status at time of surgery, as registered in the Danish Ventral Hernia Database

You may not qualify if:

  • Hernia type misclassification (based on manual medical file review)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Digestive Disease Center, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Hernia, Umbilical

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, VentralHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2025

First Posted

January 20, 2025

Study Start

February 1, 2024

Primary Completion

November 1, 2024

Study Completion

December 31, 2025

Last Updated

January 23, 2025

Record last verified: 2025-01

Locations

DK(1)