Risk Factors for Poor Outcome After Epigastric and Umbili... | NCT01665859

Studies
Risk Factors for Poor Outcome After Epigastric and Umbilical Hernia Repair

NCT01665859

Sponsor

Zealand University Hospital

Status

Completed

Last Update Posted

Jul 13, 2023Actual

Enrollment

6,783Actual

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

Status Module

Record Verification Date

Jul 2023

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

Jan 2011Actual

Completion Date

Jul 2012Actual

First Submitted Date

Aug 13, 2012

First Submission Date that Met QC Criteria

Aug 13, 2012

First Posted Date

Aug 15, 2012Estimated

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

Jul 12, 2023

Last Update Posted Date

Jul 13, 2023Actual

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

Umbilical and epigastric hernia repairs are common and performed by numerous surgical techniques. Considering that the hernia repairs in general are relatively small and simple procedures there are disproportionate poor results.

The aim of present study is to determine surgical risk factors for readmission after umbilical and epigastric hernia repair and to report risk factors for later reoperation for recurrence.

Detailed Description

All elective umbilical or epigastric hernias registered in the Danish Ventral Hernia Database are included in the study. The included patients will be followed in up to 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

Not provided

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

6,783Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Danish Ventral 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
readmission	Riskfactors for readmission within 30 days after umbilical or epigastric hernia repair	30 days

Secondary Outcomes

Measure	Description	Time Frame
reoperation for recurrence	Risk factors for recurrence repair after umbilical or epigastric hernia repair	up to 4 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Umbilical or epigastric hernia repair

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

All elective umbilical or epigastric 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
Frederik Helgstrand, MD	dept. surgery, Køge sygehus, Denmark	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D006554	Hernia, Umbilical
D012008	Recurrence
D006547	Hernia

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