NCT01430676

Brief Summary

The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DVHD to uncover risk factors for readmission, reoperation (any indication), death and reoperation for recurrence after incisional hernia repair.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,460

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

4 years

First QC Date

September 5, 2011

Last Update Submit

June 26, 2018

Conditions

Incisional Hernia

Keywords

Incisional herniarecurrencelongterm

Outcome Measures

Primary Outcomes (4)

  • Recurrence repair

    Risk factors for recurrence repair after incisional hernia repair

    up to 4 years

  • Readmission

    Riskfactors for readmission within 30 days after incisional hernia repair

    30 days after operation

  • Reoperation

    Riskfactors for reoperation (any procedure) within 30 days after incisional hernia repair

    30 days

  • Death

    Riskfactors for death within 30 days after incisional hernia repair

    30 days

Study Arms (1)

Danish Ventral Hernia Database

Patients registered in the Danish Ventral Hernia Database during January 1st 2007 to december 31st 2010

Procedure: differences in surgical techniques

Interventions

differences in surgical techniquesPROCEDURE

follow the risk for morbidity after incisional hernia repair

Danish Ventral Hernia Database

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Incisional hernia repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Køge Hospital

Køge, 4600, Denmark

Location

MeSH Terms

Conditions

Incisional HerniaRecurrence

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesDisease Attributes

Study Officials

  • Frederik Helgstrand, MD

    dept. surgery, Køge sygehus, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.

Study Record Dates

First Submitted

September 5, 2011

First Posted

September 8, 2011

Study Start

January 1, 2007

Primary Completion

January 1, 2011

Study Completion

November 1, 2011

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations

DK(1)