Pilot Study to Identify the Influence of Genetic Profile Aberrations on Patients With Recurrent Hernias

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University of Missouri-Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00527670
First received: September 7, 2007
Last updated: August 17, 2009
Last verified: August 2009
  Purpose

The aim of this study is to compare collagen composition in the skin and fascia of patients with recurrent or incisional hernias versus normal controls. We will identify potential genes responsible for genetic alterations in collagen deposition by using gene chip analysis of the tissue obtained and comparing the hernia group versus controls. The ultimate goal of this study is to identify target genes which may help us eventually predict which patients are at risk for developing post-operative hernias.


Condition Intervention
Pathological Processes
Other: No Intervention

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pilot Study to Identify the Influence of Genetic Profile Aberrations on Patients With Recurrent Hernias

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Biospecimen Retention:   Samples With DNA

Tissue samples.


Estimated Enrollment: 60
Study Start Date: August 2007
Estimated Study Completion Date: August 2008
Groups/Cohorts Assigned Interventions
NC
Normal Controls-healthy patients undergoing laparoscopic surgery for cholelithiasis, appendicitis, and adrenalectomy.
Other: No Intervention
NC is the control group to compare genomic information.
RH
Recurrent Hernia-patients presenting for laparoscopic repair of ventral or incisional hernias.
Other: No Intervention
RH is the group we are trying to find genetic proof of hernias being inherited.

Detailed Description:

This is a prospective, case control pilot study with the aim of identifying potential genetic influences on recurrent hernia formation. Patients with recurrent abdominal hernias will be compared with normal control subjects. The study endpoints will compare tissue collagen I/III ratios between the groups. It will also use gene chip technology to identify potential differences in gene expression between the two groups, followed by confirmation of the differential expression using RT-PCR.

Patients will be enrolled from the surgical clinic population. If they consent to the study, both the hernia group and the control group will have 0.5 x 0.5 x 0.1 cm3 pieces of skin and fascia collected at the time of their surgery. A small piece of tissue will be used for immunofluorescene to study collagen I/III ratios. RNA will be extracted from the rest of the tissue for the genetic studies.

  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

Surgical patients at the University of Missouri Healthcare system.

Criteria

Inclusion Criteria:

  • Hernia Group: Diagnosis of ventral or incisional hernia.
  • Control Group: appendicitis, symptomatic cholelithiasis or cholecystitis, adrenal disease necessitating adrenalectomy.
  • Scheduled for an appropriate laparoscopic repair of above diagnosis.
  • Females only: Not pregnant.

Exclusion Criteria:

  • Steroid use
  • Severe COPD or pulmonary disorders
  • History of a connective tissue disorder
  • Presentation for surgery with a diagnosis other than those listed above in inclusion criteria
  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: NCT00527670

Contacts
Contact: Sharon L. Bachman, MD 573-884-4003 bachmans@missouri.edu
Contact: Bruce Ramshaw, MD 573-884-5670 ramshawb@health.missouri.edu

Locations
United States, Missouri
University of Missouri Hospital and Clinics Recruiting
Columbia, Missouri, United States, 65212
Contact: Sharon L. Bachman, MD    573-884-4003    bachmans@missouri.edu   
Contact: Bruce Ramshaw, MD    573-884-5670    ramshawb@health.missouri.edu   
Sub-Investigator: Sharon Bachman, MD         
Sub-Investigator: Robert Calaluce, MD         
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Bruce Ramshaw, MD University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Bruce Ramshaw, MD, University of Missouri Healthcare
ClinicalTrials.gov Identifier: NCT00527670     History of Changes
Other Study ID Numbers: MO-1057938
Study First Received: September 7, 2007
Last Updated: August 17, 2009
Health Authority: United States: Federal Government

Keywords provided by University of Missouri-Columbia:
Genomics

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014