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

Pathological Processes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00527670
• Other study ID #: MO-1057938
• Status: Terminated
• Phase: N/A
• First received: September 7, 2007
• Last updated: August 5, 2016
• Start date: August 2007
• Est. completion date: November 2010

Study information

• Verified date: August 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pathologic Processes
• Pathological Processes

Intervention

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
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.

Locations

Country	Name	City	State
United States	University of Missouri Hospital and Clinics	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States,