Long-term Recurrence and Other Complications Requiring Surgery Following Primary Ventral Hernia Repair

NCT ID: NCT06783036

Last Updated: 2025-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

7200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Cohort based on patients registered in the Danish Ventral Hernia Database. Through cross-linking at an individual level, all subsequent operations will be identified in the Danish National Patient Registry. For all potentially related reoperations, patient charts will be retrieved and manually reviewed. Furthermore cross-linkage with the Danish Civil Registration System to retrieve information on civil status. Follow up from time of operation for primary ventral hernia repair (index operation) until reoperation, death, emigration or end of follow up (December 31, 2023), whichever comes first.

Conditions

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Umbilical Hernia Epigastric Hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Emergency umbilical hernia repair

no study intervention

No interventions assigned to this group

Elective umbilical hernia repair

no study intervention

No interventions assigned to this group

Emergency epigastric hernia repair

no study intervention

No interventions assigned to this group

Elective epigastric hernia repair

no study intervention

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Hernia type misclassification (based on manual medical file review)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erling Oma

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Digestive Disease Center, Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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R-23045342

Identifier Type: OTHER

Identifier Source: secondary_id

DHDB-2023-04-03

Identifier Type: OTHER

Identifier Source: secondary_id

FSEID-00006723

Identifier Type: OTHER

Identifier Source: secondary_id

P-2023-193

Identifier Type: -

Identifier Source: org_study_id

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