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CompletedNCT01997619Updated Nov 28, 2013

Biological Mesh Repair of Complex Hernias in High Risk Patients

An observational study in Hernia, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-11-28.

Sponsored by Rigshospitalet, Denmark · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
16
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description

Obervational study

Primare outcome: Surgical site occurence

Secondary outcome: Hernia recurrence

Biolocal mesh: Ventral hernia repair in a population with severe co-morbidity and contaminated hernia.

02

Conditions studied

  • Hernia

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Keywords

  • biological mesh
  • contaminated hernia
  • abdominal wall reconstruction
03

In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's enrollment of 16 is below the median of 120 across 327 observational studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

16 consecutive patients with biological mesh repair

Eligibility criteria

Inclusion Criteria: Abdominal wall reconstruction with biological mesh -

Exclusion Criteria: Pregancy,

-

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
16 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. surgical site occurence

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

    Time frame: 30 days

Secondary outcomes

  1. hernia recurrence

    Hernia recurrence at the hernia implant site

    Time frame: 20 months

07

Study locations

1 site
  • Rigshospitalet
    Copenhagen, 2100, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01997619
Lead sponsor
Rigshospitalet, Denmark
Responsible party
Louise Preisler (MD, Rigshospitalet, Denmark) — Principal investigator
First posted
Nov 28, 2013
Start date
Nov 2011
Primary completion
Jun 2013
Completion
Nov 2013
Last update
Nov 28, 2013

Study contacts

Linda Bardram, MD
study chair · Rigshospitalet, Copenhagen, University of Copenhagen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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