Genetic Examination of Patients With Primary Multiple Hernia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Herlev Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00979095
First received: September 15, 2009
Last updated: October 12, 2010
Last verified: October 2010
  Purpose

The investigators are performing a genetic study of patients with multiple hernias (at least 3 primary hernias) versus a healthy control group. This genetic information is compared with circulating and subcutaneously biomarkers such as matrix-metalloproteinases (MMP's).

The hypothesis is that patients with multiple hernias have different expression of specific genes compared to the healthy control group.


Condition
Multiple Hernia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genetic Differences Between Patients With Multiple Hernia and a Healthy Control Group

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Genetic expression of relevant genes between the groups [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of serological biomarkers (MMP's) correlated to gene expression [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Multiple hernia
Patients with more than 3 primary hernias
Control group
Patients without hernias

Detailed Description:

Other examinations performed on the patients enrolled in this study:

  • Ultrasound (US) examination of the abdominal aorta to discover possible abdominal aortic aneurysms.
  • Beightons score to evaluate the degree of joint hypermobility.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Danish citizens. Data have been retracted from The Danish Hernia Database.

Criteria

Inclusion Criteria:

  • Patients with minimum 3 primary hernias

Exclusion Criteria:

  • Patients under 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979095

Locations
Denmark
Jacob Rosenberg Recruiting
Herlev Hospital, Herev, Denmark, 2730
Contact: Jakob Burcharth, MD    44884488 ext 89434    jakobburcharth@gmail.com   
Principal Investigator: Jakob Burcharth, MD         
Sponsors and Collaborators
Herlev Hospital
Investigators
Study Director: Jacob Rosenberg, Prof. MD Herlev Hospital
Principal Investigator: Jakob Burcharth, MD Herlev Hospital
  More Information

No publications provided

Responsible Party: Jakob Burcharth, MD., Herlev Hospital
ClinicalTrials.gov Identifier: NCT00979095     History of Changes
Other Study ID Numbers: H-D-2008-126
Study First Received: September 15, 2009
Last Updated: October 12, 2010
Health Authority: Denmark: Ethics Committee

Keywords provided by Herlev Hospital:
multiple hernia

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 16, 2014