Hernia Prevention in Stomas

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prevention of Parastomal Hernias and Incisional Hernias in Old Stoma Wounds: a Pilot Study

Conditions
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Incisional Hernia, Parastomal Hernia

Intervention / Treatment
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* Device: Parietex Parastomal Mesh


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mesh placement<br> | Device: Parietex Parastomal Mesh<br>* mesh placed intraperitoneally around the stoma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stoma complications (stenosis, bulging, prolapse, retraction, skin problems) |  | two years after placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stoma