NCT02734563

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
174

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

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

January 1, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

3.6 years

First QC Date

April 1, 2016

Last Update Submit

July 14, 2017

Conditions

Hernia, Abdominal

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Control group

Males without any history or presence of hernias

Other: Collagen turnover

Interventions

Collagen turnoverOTHER

Type IV and V collagen synthesis and breakdown

Control groupMultiple hernia group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, NV, DK-2400, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood

MeSH Terms

Conditions

Hernia, Abdominal

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Lars N Jorgensen, MD

    Bispebjerg Hospital, Dept. of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 12, 2016

Study Start

January 1, 2011

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

July 18, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)