Collagen Alterations in Patients With Abdominal Wall Hernias

Hernia, Abdominal Clinical Trial

Official title:

Collagen Alterations in Patients With Abdominal Wall Hernias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02734563
• Other study ID #: H.A-2009-045
• Status: Completed
• Phase: N/A
• First received: April 1, 2016
• Last updated: July 14, 2017
• Start date: January 2011
• Est. completion date: December 2014

Study information

• Verified date: July 2017
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hernia
• Hernia, Abdominal
• Hernia, Ventral

Intervention

Other:
• Collagen turnover
Type IV and V collagen synthesis and breakdown

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	NV

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type IV and V collagen synthesis and breakdown	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