Incisional Hernia Clinical Trial
Official title:
Prevention of Parastomal Hernias and Incisional Hernias in Old Stoma Wounds: a Pilot Study
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | April 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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: - American Society of Anaesthesiologists (ASA) score IV or above - Incapacitated adult or no signed informed consent - Emergency procedure - Contaminated or infected abdomen - Residual intraperitoneal mesh - Already injured part of the abdominal wall where the stoma will be sited - Contraindication to laparoscopy - Longterm use of corticosteroids and other immunosuppressive agents - Current antibiotic therapy - One of the following conditions: immune deficiency, chemotherapy, ascites, peritoneal dialysis, pregnancy |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Centre | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Marc Schreinemacher |
Netherlands,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | postoperative complications after prophylactic mesh placement around a stoma (i.e., infection of the mesh and adhesions to the mesh) | one year after placement | Yes | |
Primary | incisional herniation at the old stoma wound | two years | No | |
Secondary | stoma complications (stenosis, bulging, prolapse, retraction, skin problems) | two years after placement | Yes |
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