NCT01589276

Brief Summary

The aim of present study was to evaluate the clinical course after emergency ventral hernia repair in terms of 30-day-readmission, -reoperation and -mortality and to identify risk factors for emergency repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10,976

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
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

4 years

First QC Date

April 26, 2012

Last Update Submit

June 26, 2018

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

  • risk factors for emergency ventral hernia repair

    evaluation of risk factors (hernia size, hernia type, type of surgery, age and gender) for poor outcome after emergency ventral hernia repair.

    4 years

Secondary Outcomes (3)

  • 30-day readmission

    30 days

  • 30-day reoperation

    30 day

  • 30-day mortality

    30 day

Study Arms (2)

Emergency hernia repairs

Elective hernia repairs

Eligibility Criteria

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

Hernia repairs registered in the Danish Ventral Hernia Database during the study period

You may qualify if:

  • All incisional, umblilical and epigastric hernia repiars

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Surgery, Køge Hospital

Køge, 4600, Denmark

Location

Related Publications (1)

  • Helgstrand F, Rosenberg J, Kehlet H, Bisgaard T. Outcomes after emergency versus elective ventral hernia repair: a prospective nationwide study. World J Surg. 2013 Oct;37(10):2273-9. doi: 10.1007/s00268-013-2123-5.

    PMID: 23756775DERIVED

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Frederik Helgstrand, MD

    dept. surgery, Køge sygehus, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 26, 2012

First Posted

May 1, 2012

Study Start

January 1, 2007

Primary Completion

January 1, 2011

Study Completion

February 1, 2012

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations

DK(1)