Study Stopped
PI left institution
Pilot Study to Identify the Influence of Genetic Profile Aberrations on Patients With Recurrent Hernias
1 other identifier
observational
41
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 7, 2007
CompletedFirst Posted
Study publicly available on registry
September 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedAugust 8, 2016
August 1, 2016
3.3 years
September 7, 2007
August 5, 2016
Conditions
Keywords
Study Arms (2)
Normal Controls
Healthy patients undergoing laparoscopic surgery for cholelithiasis, appendicitis, and adrenalectomy.
Recurrent Hernia
Patients presenting for laparoscopic repair of ventral or incisional hernias.
Interventions
The control group will have small slivers of tissue removed from the skin and abdomen during surgery to compare genomic information.
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.
Eligibility Criteria
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
Biospecimen
Tissue samples.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce Ramshaw, MD
University of Missouri-Columbia
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