Pilot Study to Identify the Influence of Genetic Profile Aberrations on Patients With Recurrent Hernias
Recruitment status was Recruiting
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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 |
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 |
Surgical patients at the University of Missouri Healthcare system.
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| Contact: Sharon L. Bachman, MD | 573-884-4003 | bachmans@missouri.edu |
| Contact: Bruce Ramshaw, MD | 573-884-5670 | ramshawb@health.missouri.edu |
| 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 | |
| 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:
|
Hernia Pathologic Processes Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 19, 2013