MRI Imaging of Retromuscular Hernia Repair With CICAT Visible®
Prospective MRI Follow-up After Retromuscular Incisional Hernia Repair Using the Dynamesh CICAT Visible® Mesh
1 other identifier
observational
10
1 country
1
Brief Summary
The aim of this study is the visualization of the mesh surface and the confirmation with MRI scan at 1 month and 13 months after standardized retromuscular incisional hernia repair with the visible CICAT mesh (Dynamesh®).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2015
Longer than P75 for all trials
1 active site
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
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 26, 2015
CompletedFirst Posted
Study publicly available on registry
June 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJanuary 20, 2021
January 1, 2021
6.6 years
May 26, 2015
January 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
visualization of the mesh surface
Clear visualization of the CICAT® prosthesis at 1 month postoperatively with MRI
1 month
Secondary Outcomes (2)
calculation of the mesh surface
up to 13 months
visualization of the mesh surface
up to 13 months
Interventions
Visualization of the mesh surface and the confirmation with MRI scan at 1 month and 13 months after standardized retromusculare incisional hernia repair with the visible CICAT mesh (Dynamesh®).
Eligibility Criteria
Adult patients scheduled for an open retromusculare repair of an incisional hernia.
You may qualify if:
- patients scheduled for an retromusculare repair of an incisional hernia
You may not qualify if:
- \<18 years
- Emergency surgery (incarcerated hernia)
- Clean-contaminated or contaminated procedures
- ASA score\> 4
- Pregnancy
- No patient Informed Consent
- Life expectancy of less than 2 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Algemeen Ziekenhuis Maria Middelareslead
- Duomedcollaborator
Study Sites (1)
AZ Maria Middelares
Ghent, 9000, Belgium
Related Publications (3)
Hansen NL, Ciritsis A, Otto J, Busch D, Kuhl CK, Kraemer NA. Utility of Magnetic Resonance Imaging to Monitor Surgical Meshes: Correlating Imaging and Clinical Outcome of Patients Undergoing Inguinal Hernia Repair. Invest Radiol. 2015 Jul;50(7):436-42. doi: 10.1097/RLI.0000000000000148.
PMID: 25756683BACKGROUNDCiritsis A, Hansen NL, Barabasch A, Kuehnert N, Otto J, Conze J, Klinge U, Kuhl CK, Kraemer NA. Time-dependent changes of magnetic resonance imaging-visible mesh implants in patients. Invest Radiol. 2014 Jul;49(7):439-44. doi: 10.1097/RLI.0000000000000051.
PMID: 24651663RESULTHansen NL, Barabasch A, Distelmaier M, Ciritsis A, Kuehnert N, Otto J, Conze J, Klinge U, Hilgers RD, Kuhl CK, Kraemer NA. First in-human magnetic resonance visualization of surgical mesh implants for inguinal hernia treatment. Invest Radiol. 2013 Nov;48(11):770-8. doi: 10.1097/RLI.0b013e31829806ce.
PMID: 23732864RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Filip Muysoms, MD. PhD
Algemeen Ziekenhuis Maria Middelares
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Department of Surgery
Study Record Dates
First Submitted
May 26, 2015
First Posted
June 2, 2015
Study Start
May 1, 2015
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
January 20, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share