Collagen Alterations in Patients With Abdominal Wall Hernias

July 14, 2017 updated by: Lars Nannestad Jorgensen, Bispebjerg Hospital
The aim of this study was to evaluate collagen turnover in patients with multiple hernias

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Venous blood was collected and markers for type IV and V collagen synthesis and breakdown was measured

Study Type

Observational

Enrollment (Actual)

174

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • NV
      • Copenhagen, NV, Denmark, DK-2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Males with multiple hernias wer identified from the Danish Hernia Database. The control group were recruited from hospital staff.

Description

Inclusion Criteria:

  • patients with a history of three hernia repairs (multiple hernia group)
  • patients without any history or presence of hernias (control group)

Exclusion Criteria:

  • connective tissue disorder (Ehlers-Danloss/Marfan)
  • presence of hernia upon clinical examination (control group)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Multiple hernia group
Males undergoing at least three repairs of abdominal wall hernias at three different anatomic locations. Collagen turnover is analysed.
Other: Collagen turnover
Type IV and V collagen synthesis and breakdown
Control group
Males without any history or presence of hernias
Other: Collagen turnover
Type IV and V collagen synthesis and breakdown

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type IV and V collagen synthesis and breakdown
Time Frame: 3 months
Products from type IV and V collagen synthesis and breakdown are measured in serum. with ELISA from Nordic Bioscience A/S, Herlev, Denmark. Specifically, the biomarker for type IV collagen synthesis (P4NP) and breakdown (C4M), and for type V collagen synthesis (P5CP) and breakdown (C5M) was measured. The concentration unit for all parameters is ng/ml.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Principal Investigator: Lars N Jorgensen, MD, Bispebjerg Hospital, Dept. of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 1, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Actual)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 14, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H.A-2009-045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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