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

August 5, 2016 updated by: University of Missouri-Columbia
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Surgical patients at the University of Missouri Healthcare system.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Bruce Ramshaw, MD, University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

September 7, 2007

First Submitted That Met QC Criteria

September 7, 2007

First Posted (Estimate)

September 11, 2007

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 5, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MO-1057938

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pathological Processes

Clinical Trials on Normal Controls

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe