NCT00484887

Brief Summary

This study will collect a large amount of hernia mesh explants and study the changes that occur in the materials in vivo to use the information to help design new mesh made from novel materials. We will have evidence that our current options are not only inadequate but can lead to complications. One of our main goals is to convince our colleagues to change their surgical practice by publishing and educating them with this data.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2007

Longer than P75 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

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2007

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

August 8, 2016

Status Verified

May 1, 2016

Enrollment Period

4.8 years

First QC Date

June 7, 2007

Last Update Submit

August 5, 2016

Conditions

Pathological Conditions, Signs and SymptomsHernia

Keywords

Hernia meshImplanted mesh materialExplanted mesh material

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:

  • Adults (persons 18 and older)
  • Previous placement of hernia mesh material
  • Current need for excision of previous mesh placement or current need for intra-abdominal surgical procedure

You may not qualify if:

  • No retained mesh prosthetic
  • Non surgical candidate

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 WITHOUT DNA

Explanted mesh from surgical procedures.

MeSH Terms

Conditions

Pathological Conditions, Signs and SymptomsHernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical

Study Officials

  • Bruce Ramshaw, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 7, 2007

First Posted

June 11, 2007

Study Start

April 1, 2007

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

August 8, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)