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Clinical Trial Summary

Knowing that the risk of stoma associated herniation (parastomal or incisional) is 30-50% and the associated morbidity significant, standard placement of a prophylactic mesh upon stoma creation might prevent parastomal (or incisional herniation, after closure) and improve the quality of life of a large group of patients. This study is meant to be a pilot study to see whether the mesh related risks of infection and adhesion morbidity are acceptable if the mesh is placed intraperitoneally.


Clinical Trial Description

The idea of a prophylactic mesh has been tested before in a Swedish randomized controlled trial (RCT) with the mesh placed upon end colostomy formation. Results suggest this procedure is the panacea against stoma associated herniations. The investigators still have unanswered questions however, about the size and ideal position of the mesh, possible complications (infection, adhesions) and the benefit in terms of quality of life. ;


Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00907842
Study type Interventional
Source Academisch Ziekenhuis Maastricht
Contact
Status Completed
Phase N/A
Start date April 2010
Completion date April 2013

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