Hernia Prevention in Stomas
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: mesh placement
|
Device: Parietex Parastomal Mesh
mesh placed intraperitoneally around the stoma
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- stoma complications (stenosis, bulging, prolapse, retraction, skin problems) [two years after placement]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult patients with a life expectancy of at least one year
-
Temporary stoma formation
-
Signed informed consent
-
Elective surgery
-
Clean-contaminated abdomen
Exclusion Criteria:
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American Society of Anaesthesiologists (ASA) score IV or above
-
Incapacitated adult or no signed informed consent
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Emergency procedure
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Contaminated or infected abdomen
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Residual intraperitoneal mesh
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Already injured part of the abdominal wall where the stoma will be sited
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Contraindication to laparoscopy
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Longterm use of corticosteroids and other immunosuppressive agents
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Current antibiotic therapy
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One of the following conditions: immune deficiency, chemotherapy, ascites, peritoneal dialysis, pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Maastricht University Medical Centre | Maastricht | Netherlands | 6200 AZ |
Sponsors and Collaborators
- Marc Schreinemacher
Investigators
- Study Director: Nicole Bouvy, MD, PhD, Maastricht University Medical Centre
- Principal Investigator: Marc Schreinemacher, MD, Maastricht University Medical Centre
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Jänes 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.
- MEC09-2-052
- NL27625.068.09