NCT01997619

Brief Summary

Complex ventral hernia repair is a significant surgical challenge with high frequencies of both wound complications and recurrence. The Ventral Hernia Working Group (VHWG) described in 2010 recommendations regarding grading and technique of repair, which we have followed since November 2011.The purpose of the this study was to evaluate our results after biologic mesh repair of complex hernias.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2011

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

November 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
Last Updated

November 28, 2013

Status Verified

November 1, 2013

Enrollment Period

1.6 years

First QC Date

November 24, 2013

Last Update Submit

November 24, 2013

Conditions

Hernia

Keywords

biological meshcontaminated herniaabdominal wall reconstruction

Outcome Measures

Primary Outcomes (1)

  • surgical site occurence

    Wound infections, redness, seromas, dehiesience at the hernia implant site

    30 days

Secondary Outcomes (1)

  • hernia recurrence

    20 months

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

16 consecutive patients with biological mesh repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Linda Bardram, MD

    Rigshospitalet, Copenhagen, University of Copenhagen

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 24, 2013

First Posted

November 28, 2013

Study Start

November 1, 2011

Primary Completion

June 1, 2013

Study Completion

November 1, 2013

Last Updated

November 28, 2013

Record last verified: 2013-11

Locations

DK(1)