NCT01501682

Brief Summary

The purpose of this study is to compare the long-term complaints after ventral hernia repair after insertion of different types of mesh compared with primary suture. Also recurrence of hernia will be discussed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2011

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

February 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
Last Updated

December 29, 2011

Status Verified

December 1, 2011

Enrollment Period

10 months

First QC Date

December 18, 2011

Last Update Submit

December 28, 2011

Conditions

Ventral Hernia

Keywords

ventralexventral hernia

Study Arms (3)

primary suture

operated with primary suture

other mesh

operated with insertion of another mesh

ventralex

operated with insertion of ventralex mesh

Eligibility Criteria

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

operated for ventral hernia from the year 2004 to the year 2009 at Koege Hospital

You may qualify if:

  • operated for ventral hernia from the year 2004 to the year 2009

You may not qualify if:

  • liver cirrhosis
  • pregnancy
  • combined hernia
  • operation for ventral hernia and other operation
  • laparoscopic operation
  • acute operation
  • recurrence of hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Koege hospital

Koege, 4600, Denmark

RECRUITING

Køge sygehus

Køge, 4600, Denmark

RECRUITING

Related Publications (1)

  • Erritzoe-Jervild L, Christoffersen MW, Helgstrand F, Bisgaard T. Long-term complaints after elective repair for small umbilical or epigastric hernias. Hernia. 2013 Apr;17(2):211-5. doi: 10.1007/s10029-012-0960-z. Epub 2012 Jul 14.

    PMID: 22797701DERIVED

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Liv Erritzøe-Jervild

    Køge Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederik helgstrand, MD

CONTACT

freh@regionsjaelland.dk

Thue Bisgaard

CONTACT

thb@regionsjaelland.dk

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
stud.med

Study Record Dates

First Submitted

December 18, 2011

First Posted

December 29, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 29, 2011

Record last verified: 2011-12

Locations

DK(2)