NCT02292264

Brief Summary

The aim of this study is to evaluate risk factors and complications of ventral hernia repair. A retrospective study of journal files with patients undergoing ventral hernia repair, and an analyses of complications by use of the Clavien-Dindo classification of surgical complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
575

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Shorter than P25 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

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

9 months

First QC Date

November 12, 2014

Last Update Submit

June 26, 2018

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

  • Identifying pre-operative risk factors by use of the Clavien Dindo classification.

    5 years

Study Arms (1)

Surgical treatment of ventral hernia

Adult patients who underwent a ventral hernia Repair at Zealand University hospital

Eligibility Criteria

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

All patients who underwent ventral hernia repair at the Surgical Department of Køge University Hospital in the timeperiod from 2009 - 2014.

You may qualify if:

  • Surgically treated ventral hernia repair

You may not qualify if:

  • All surgically treated patients are included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Køge University Hospital

Køge, 4600, Denmark

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Henrik Sjølander, 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

November 12, 2014

First Posted

November 17, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations

DK(1)