NCT02263612

Brief Summary

The Danish Hernia Database (DHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DHD to uncover risk factors for long-term (30 days postoperative and later) readmission, reoperation, death and reoperation for recurrence after incisional hernia repair with use of a synthetic mesh.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,258

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
7.7 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

8.7 years

First QC Date

September 20, 2014

Last Update Submit

June 26, 2018

Conditions

Incisional Hernia

Keywords

Incisional HerniaComplicationsLong-term

Outcome Measures

Primary Outcomes (1)

  • Reoperation

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

    Up to 7 years

Secondary Outcomes (1)

  • Readmission

    Up to 7 years

Other Outcomes (1)

  • Death

    Up to 7 years

Study Arms (1)

Danish Hernia Database

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

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 Sygehus

Køge, 4600, Denmark

Location

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Dunja Kokotovic, MS

    dept. of surgery, Køge University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 20, 2014

First Posted

October 13, 2014

Study Start

January 1, 2007

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations

DK(1)