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Collagen Alterations in Patients With Abdominal Wall Hernias

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02734563
Recruitment Status : Completed
First Posted : April 12, 2016
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Lars Nannestad Jorgensen, Bispebjerg Hospital

Brief Summary:
The aim of this study was to evaluate collagen turnover in patients with multiple hernias

Condition or disease Intervention/treatment
Hernia, Abdominal Other: Collagen turnover

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

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Study Type : Observational
Actual Enrollment : 174 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Collagen Alterations in Patients With Abdominal Wall Hernias
Study Start Date : January 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
Drug Information available for: Collagen

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




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Venous blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734563


Locations
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Denmark
Bispebjerg Hospital
Copenhagen, NV, Denmark, DK-2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
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Principal Investigator: Lars N Jorgensen, MD Bispebjerg Hospital, Dept. of Surgery

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Responsible Party: Lars Nannestad Jorgensen, Professor, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02734563    
Other Study ID Numbers: H.A-2009-045
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Hernia, Abdominal
Pathological Conditions, Anatomical