Late Mesh Complications After 3258 Incisional Hernia Oper... | NCT02263612

Studies
Late Mesh Complications After 3258 Incisional Hernia Operations

NCT02263612

Sponsor

Zealand University Hospital

Status

Completed

Last Update Posted

Jun 27, 2018Actual

Enrollment

3,258Actual

Phase

Not provided

Conditions

Incisional 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

Status Module

Record Verification Date

Jun 2018

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

Jan 2007

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Sep 20, 2014

First Submission Date that Met QC Criteria

Oct 8, 2014

First Posted Date

Oct 13, 2014Estimated

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

Jun 26, 2018

Last Update Posted Date

Jun 27, 2018Actual

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 Danish Hernia Database (DHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DHD to uncover risk factors for long-term (30 days postoperative and later) readmission, reoperation, death and reoperation for recurrence after incisional hernia repair with use of a synthetic mesh.

Detailed Description

All principal incisional hernias registered in the Danish Hernia Database are included in the study. The included patients have been followed for more than 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.

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

3,258Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Danish Hernia Database		Patients registered in the Danish Ventral Hernia Database during January 1st 2007 to december 31st 2010

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reoperation	Riskfactors for reoperation (any procedure) more than 30 days after incisional hernia repair	Up to 7 years

Secondary Outcomes

Measure	Description	Time Frame
Readmission	Riskfactors for readmission later than 30 days after incisional hernia repair	Up to 7 years

Other Outcomes

Measure	Description	Time Frame
Death	Riskfactors for death later than 30 days after incisional hernia repair	Up to 7 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Incisional Hernia Repair

Accepts Healthy Volunteers

Yes

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

All incisional hernia repairs registered in tha Danish National Hernia Database from January 1st 2007 to December 31st 2010

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dunja Kokotovic, MS	dept. of surgery, Køge University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Køge Sygehus		Køge		4600	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000069290	Incisional Hernia

Ancestor Terms

ID	Term
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided