Reoperation Rate Versus Clinical Recurrence After Ventral... | NCT01325246

Studies
Reoperation Rate Versus Clinical Recurrence After Ventral Hernia Repair

NCT01325246

Sponsor

Zealand University Hospital

Status

Completed

Last Update Posted

Aug 15, 2024Actual

Enrollment

945Actual

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

Aug 2024

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 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Sep 14, 2010

First Submission Date that Met QC Criteria

Mar 28, 2011

First Posted Date

Mar 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

Aug 14, 2024

Last Update Posted Date

Aug 15, 2024Actual

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 risk for recurrence after ventral hernia repair is often based on reoperation rates with short follow-up rather than recurrences identified by clinical examinations.

The purpose of current study is find the real incidence of recurrences 3 years after ventral hernia repair and to compare with the reoperation rate.

Detailed Description

all patients in a restricted area (all patients in the part of Denmark called Zealand) who had a ventral hernia repair in 2007 (appr. 1200 patients). The patients will be sorted by a questionnaire and if the patients are suspicious for recurrence they will be offered a clinical examination.

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

945Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical recurrence after ventral hernia repair		up to 4 years

Secondary Outcomes

Measure	Description	Time Frame
explanations for not having a recurrence repair		up to 4 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary ventral hernia repair performed in the region of Zealand in Denmark

Exclusion Criteria:

Patients who died and patients not resident in region Zealand

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

1200 patients who had a ventral hernia repair in 2007

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frederik Helgstrand, MD	dept. of surgery, Køge Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of surgery, Køge Hospital		Køge		4600	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22580941	Derived	Helgstrand F, Rosenberg J, Kehlet H, Strandfelt P, Bisgaard T. Reoperation versus clinical recurrence rate after ventral hernia repair. Ann Surg. 2012 Dec;256(6):955-8. doi: 10.1097/SLA.0b013e318254f5b9.

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