Does Pregnancy Increase Risk of Ventral Hernia Recurrence? | NCT02564757

Studies
Does Pregnancy Increase Risk of Ventral Hernia Recurrence?

NCT02564757

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

Jan 31, 2017Estimated

Enrollment

3,578Actual

Phase

Not provided

Conditions

Recurrent Hernia of Anterior Abdominal Wall

Interventions

Not provided

Countries

Not provided

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

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Jan 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Sep 29, 2015

First Submission Date that Met QC Criteria

Sep 29, 2015

First Posted Date

Oct 1, 2015Estimated

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 30, 2017

Last Update Posted Date

Jan 31, 2017Estimated

Name	Class
University of Copenhagen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators will examine if pregnancy increases risk of ventral hernia recurrence

Detailed Description

The investigators will establish a cohort of female fertile patients who underwent ventral hernia repair (Umbilical, Epigastric and Incisional hernia repair) registered in the Danish Hernia Database. The investigators will link these data at an individual level with the Danish National Patient Registry (DNPR), Danish Medical Birth Registry (DMBR) and the Danish Civil Registry (CPR).

From DMBR, subsequent pregnancies in the study cohort will be noted. From DNPR, ventral hernia recurrence, defined as clinical recurrence and/or reoperation for recurrence will be noted. Cases registered with both clinical recurrence and reoperation for recurrence, the date of the earliest registration will be defined as the date of ventral hernia recurrence.

From CPR, date of death or emigration will be noted.

Through an extended Cox regression analysis, handling pregnancy as a time-dependent variable, the investigators will examine whether pregnancy is associated with an increased risk of ventral hernia recurrence.

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

3,578Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence	Clinical ventral hernia recurrence will be defined as clinical recurrence retrieved from the Danish National Patient Registry.	0-7 years
Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence Repair	Ventral hernia recurrence repair will be defined as reoperation retrieved from the Danish National Patient Registry.	0-8 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fertile female patient

Exclusion Criteria:

non-Danish citizen

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Fertile female patients who have undergone ventral hernia repair

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars N Jorgensen, MD, DMSc	Bispebjerg Hospital, University of Copenhagen	Study Chair

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D046449	Hernia, Abdominal

Ancestor Terms

ID	Term
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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