Long Term Complaints After Elective Repair for Small Umbi... | NCT01501682

Studies
Long Term Complaints After Elective Repair for Small Umbilical or Epigastric Hernias

NCT01501682

Sponsor

Zealand University Hospital

Status

Unknown status

Last Update Posted

Dec 29, 2011Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Ventral 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

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Dec 18, 2011

First Submission Date that Met QC Criteria

Dec 28, 2011

First Posted Date

Dec 29, 2011Estimated

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

Dec 28, 2011

Last Update Posted Date

Dec 29, 2011Estimated

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 purpose of this study is to compare the long-term complaints after ventral hernia repair after insertion of different types of mesh compared with primary suture. Also recurrence of hernia will be discussed.

Detailed Description

The purpose of this study is to compare the long-term complaints after ventral hernia repair after insertion of different types of mesh compared with primary suture. Based on a questionnaire selected patients will be invited to clinical examination for recurrence and more detailed interview.

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

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
primary suture		operated with primary suture
other mesh		operated with insertion of another mesh
ventralex		operated with insertion of ventralex mesh

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

operated for ventral hernia from the year 2004 to the year 2009

Exclusion Criteria:

liver cirrhosis
pregnancy
combined hernia
operation for ventral hernia and other operation
laparoscopic operation
acute operation
recurrence of hernia

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

operated for ventral hernia from the year 2004 to the year 2009 at Koege Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Frederik helgstrand, MD	Contact			freh@regionsjaelland.dk
Thue Bisgaard	Contact			thb@regionsjaelland.dk

Overall Officials

Name	Affiliation	Role
Liv Erritzøe-Jervild	Køge Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Koege hospital	Recruiting	Koege		4600	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22797701	Derived	Erritzoe-Jervild L, Christoffersen MW, Helgstrand F, Bisgaard T. Long-term complaints after elective repair for small umbilical or epigastric hernias. Hernia. 2013 Apr;17(2):211-5. doi: 10.1007/s10029-012-0960-z. Epub 2012 Jul 14.

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms