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| ID | Type | Description | Link |
|---|---|---|---|
| NL27625.068.09 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mesh placement | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parietex Parastomal Mesh | Device | mesh placed intraperitoneally around the stoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complications after prophylactic mesh placement around a stoma (i.e., infection of the mesh and adhesions to the mesh) | one year after placement | |
| incisional herniation at the old stoma wound | two years |
| Measure | Description | Time Frame |
|---|---|---|
| stoma complications (stenosis, bulging, prolapse, retraction, skin problems) | two years after placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Bouvy, MD, PhD | Maastricht University Medical Centre | Study Director |
| Marc Schreinemacher, MD | Maastricht University Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Centre | Maastricht | 6200 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19011935 | Background | Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh: a 5-year follow-up of a randomized study. World J Surg. 2009 Jan;33(1):118-21; discussion 122-3. doi: 10.1007/s00268-008-9785-4. | |
| 17120189 | Background | Cingi A, Cakir T, Sever A, Aktan AO. Enterostomy site hernias: a clinical and computerized tomographic evaluation. Dis Colon Rectum. 2006 Oct;49(10):1559-63. doi: 10.1007/s10350-006-0681-4. |
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| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| D010335 | Pathologic Processes |