Long-term Recurrence and Other Complications Requiring Su... | NCT06783036

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

NCT06783036

Sponsor

Bispebjerg Hospital

Status

Active, not recruiting

Last Update Posted

Jan 23, 2025Actual

Enrollment

7,200Estimated

Phase

Not provided

Conditions

Umbilical Hernia
Epigastric Hernia

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
R-23045342	Other Identifier	Team for journaldata, Center for sundhed
DHDB-2023-04-03	Other Identifier	Dansk herniedatabase
FSEID-00006723	Other Identifier	Sundhedsdatastyrelsen

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2024Actual

Primary Completion Date

Nov 1, 2024Actual

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jan 14, 2025

First Submission Date that Met QC Criteria

Jan 14, 2025

First Posted Date

Jan 20, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2025

Last Update Posted Date

Jan 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Operation for hernia recurrence		Until december 31, 2023

Secondary Outcomes

Measure	Description	Time Frame
Operation for non-recurrence complication		Until december 31, 2023

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Nationwide population of patients registered in the Danish Ventral Hernia Database

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Digestive Disease Center, Bispebjerg Hospital		Copenhagen		2400	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006554	Hernia, Umbilical

Ancestor Terms

ID	Term
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006555	Hernia, Ventral
D046449	Hernia, Abdominal

Browse Leaves

Not provided

Browse Branches

Not provided