Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh

Study Overview
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Brief Summary
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Specific aim: To compare patients with colostomies with or without mesh at the primary operation. Primary endpoint is the incidence of parastomal hernia requiring surgery. All patients at participating centers scheduled for permanent colostomy, after signing informed consent and meeting inclusion criteria, will be randomised to formation of a stoma with or without mesh. If the inclusion criteria is fulfilled and informed consent is signed, the patient is randomised preoperatively.

Detailed Description
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Parastomal hernia is a relatively common and troublesome complication in patients with a stoma. The exact incidence is not known and depending on definitions and if a bulging is a hernia or not, as well as when after the operation the examination is performed, the incidence varies between 0-48%. A parastomal hernia may give the patient difficulties with appliance and leakage. From an economical point of view a stoma that requires special kinds of appliances is expensive. Theoretically, strengthening of the abdominal wall with a mesh at the the primary operation would reduce the risk for parastomal hernia. Recently presented data suggest that a mesh at the primary operation really does reduce the risk to develop a parastomal hernia. No negative side effects with the use of a mesh have been reported in these studies. All earlier studies have involved relatively small numbers of patients and short times of observation, and therefore under-dimensioned concerning potential negative late side-effects. Complications seen in other studies where mesh has been used in surgery of the bowel include fistulas and infections among others. To understand if mesh at the primary operation, in a safe way, reduces the risk for developing parastomal hernia compared to conventional surgery, is important to perform this new prospective randomised multicenter trial. Specific aim: To compare patients with colostomies with or without mesh at the primary operation. Primary endpoint is the incidence of parastomal hernia requiring surgery. All patients at participating centers scheduled for permanent colostomy, after signing informed consent and meeting inclusion criteria, will be randomised to formation of a stoma with or without mesh. If the inclusion criteria is fulfilled and informed consent is signed, the patient is randomised preoperatively.

Official Title
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STOMAMESH Prospective Randomised Multicenter Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh

Conditions
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Parastomal Hernia

Intervention / Treatment
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* Device: Polypropylene Mesh, density 25-40g/square meter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is scheduled for permanent colostomy elective or acute operation. The optimal site for stoma is marked preoperatively. No previous stoma. Over the age of 18. Informed consent signed by the patient. Exclusion Criteria: Expected lifetime less then 3 years. Fecal peritonitis (perforated bowel with free intestinal content in the peritoneal cavity). Previous stoma.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colostomy with a prophylactic mesh<br> | Device: Polypropylene Mesh, density 25-40g/square meter<br>* colostomy with a prophylactic hernia mesh<br>|
| No Intervention: Colostomy without a prophylactic mesh<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of parastomal hernias in the two groups at 12 and 36 months postoperatively |  | At 12 and 36 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life related to health |  | At 12 and 36 months postoperatively | 
| The health care systems total cost related to the stoma |  | At 12 and 36 months postoperatively | 
| Rate of infections 30 days postoperatively |  | At 30 days postoperatively | 
| Late complication related to the mesh leading to surgery |  | At 12 and 36 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parastomal hernia, prophylactic mesh, colostomy, hernia