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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pathological Processes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal Controls

Healthy patients undergoing laparoscopic surgery for cholelithiasis, appendicitis, and adrenalectomy.

Normal Controls

Intervention Type PROCEDURE

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.

Recurrent Hernia

Intervention Type PROCEDURE

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.

Interventions

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Normal Controls

The control group will have small slivers of tissue removed from the skin and abdomen during surgery to compare genomic information.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.