Prospective Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias (SITUP)
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|ClinicalTrials.gov Identifier: NCT01639118|
Recruitment Status : Terminated (Perception of an increased incidence of C-Qur V-patch mesh infection, with need for removal, compared to other meshes used for umbilical hernia repair.)
First Posted : July 12, 2012
Last Update Posted : November 20, 2012
Primary ventral hernias, such as umbilical and epigastric hernias, are best repaired with abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh technology have been developed for the specific indication of small ventral hernias; this technique is very attractive because the mesh can be introduced through a nearly invisible scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No literature is available on the adequate size of mesh needed to repair a hernia defect of an umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a large mesh device. Small hernias might benefit of repair with a small mesh device so no enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size to have more overlap of the mesh beyond the hernia defect.
With this prospective cohort study the investigators want to explore the efficacy of C-QUR V-Patch of different sizes for the different sizes of hernia defects.
|Condition or disease|
|Ventral Hernia Umbilical Hernia Epigastric Hernia|
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||Prospective Observational Cohort Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639118
|AZ Maria Middelares|
|Ghent, Oost Vlaanderen, Belgium, 9000|
|Principal Investigator:||Stijn De Sutter, MD||Algemeen Ziekenhuis Maria Middelares|
|Study Director:||Filip Muysoms, MD||Algemeen Ziekenhuis Maria Middelares|
|Study Chair:||Iris Kyle-Leinhase, PhD||Algemeen Ziekenhuis Maria Middelares|