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

University of Missouri (MU)

Status: Terminated

Conditions: Pathological Processes

Treatments: Procedure: Recurrent Hernia; Procedure: Normal Controls

Study type: Observational

Funder types: Other

Identifiers

NCT00527670

MO-1057938

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

41 participants in 2 patient groups

Normal Controls

Description:

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

Treatment:

Procedure: Normal Controls

Recurrent Hernia

Description:

Patients presenting for laparoscopic repair of ventral or incisional hernias.

Treatment:

Procedure: Recurrent Hernia