NCT00527670

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

3.3 years

First QC Date

September 7, 2007

Last Update Submit

August 5, 2016

Conditions

Keywords

Genomics

Study Arms (2)

Normal Controls

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

Procedure: Normal Controls

Recurrent Hernia

Patients presenting for laparoscopic repair of ventral or incisional hernias.

Procedure: Recurrent Hernia

Interventions

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

Normal Controls

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.

Recurrent Hernia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical patients at the University of Missouri Healthcare system.

You may qualify if:

  • 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.

You may not qualify if:

  • Steroid use
  • Severe COPD or pulmonary disorders
  • History of a connective tissue disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri Hospital and Clinics

Columbia, Missouri, 65212, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples.

MeSH Terms

Conditions

Pathologic Processes

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

  • Bruce Ramshaw, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2007

First Posted

September 11, 2007

Study Start

August 1, 2007

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

August 8, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations