NCT01484743

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 parastomal hernia repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P50-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
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

3.9 years

First QC Date

November 30, 2011

Last Update Submit

June 26, 2018

Conditions

Parastomal Hernia

Keywords

recurrencereadmissionreoperationmortalitymorbidity

Outcome Measures

Primary Outcomes (1)

  • Recurrence repair

    Surgical risk factors for recurrence repair after parastomal hernia repair.

    up to 4 years after operation

Study Arms (1)

Patients with parastomal hernia repair

Patients registered in the Danish Ventral Hernia database

Procedure: differences in surgical techniques

Interventions

differences in surgical techniquesPROCEDURE

follow the risk for morbidity after incisional hernia repair

Patients with parastomal hernia repair

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 the Danish National Hernia Database from January 1st 2007 to December 31st 2010

You may qualify if:

  • All parastomal hernia repairs registered in the Danish National Ventral Hernia Database

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Køge Hospital

Køge, Region Sjælland, 4600, Denmark

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Frederik Helgstrand, MD

    Dept. surgery Koege hospital

    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

November 30, 2011

First Posted

December 2, 2011

Study Start

January 1, 2007

Primary Completion

December 1, 2010

Study Completion

October 1, 2011

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations

DK(1)