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

This study has been terminated.
(PI left institution)
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00527670
First received: September 7, 2007
Last updated: August 5, 2016
Last verified: August 2016
  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
Procedure: Normal Controls
Procedure: Recurrent Hernia

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.

Enrollment: 41
Study Start Date: August 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Normal Controls
Healthy patients undergoing laparoscopic surgery for cholelithiasis, appendicitis, and adrenalectomy.
Procedure: Normal Controls
The control group will have small slivers of tissue removed from the skin and abdomen during surgery to compare genomic information.
Recurrent Hernia
Patients presenting for laparoscopic repair of ventral or incisional hernias.
Procedure: Recurrent Hernia
This group will have small slivers of tissue removed from the skin and abdomen during hernia repair surgery 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   (Adult, Senior)
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

Locations
United States, Missouri
University of Missouri Hospital and Clinics
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Bruce Ramshaw, MD University of Missouri-Columbia
  More Information

Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00527670     History of Changes
Other Study ID Numbers: MO-1057938 
Study First Received: September 7, 2007
Last Updated: August 5, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Missouri-Columbia:
Genomics

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on December 02, 2016