A randomised controlled trial of Permacol® reinforcement of permanent stomas versus standard technique in reduction of parastomal hernia

INTERVENTION: We intend to randomise a cohort of patients who are undergoing permanent stoma formation for a variety of elective procedures between collagen mesh reinforcement of the stoma versus no mesh as control. CONDITION: Parastomal herniation ; Digestive System ; Parastomal herniation PRIMARY OUTCOME: 1. To determine the efficacy of Permacol® in reducing the incidence of parastomal hernia; 2. To test whether the use of collagen mesh reinforcement is associated with lower rates of clinical herniation than no reinforcement. This will be evaluated at discharge and one, six, 12, 18 and 24 months post‐operatively. SECONDARY OUTCOME: The secondary objectives of the study will be to determine differences in:; 1. The radiological incidence of herniation as detected by Computerised Tomography (CT) scan and correlate this with the primary objective at 12 months; 2. Complications associated with the technique used for the reinforcement. These will be evaluated at discharge and one, six, 12, 18 and 24 months post‐operatively.; 3. The handling characteristics, ease of insertion and suturing of the implant will be evaluated by the surgeon; 4. Cost‐benefit analysis comparing the cost of the reinforcement technique and the length of stay; 5. Quality of life assessed using short‐form‐36 questionnaire (SF36) version two and EuroQol EQ‐5D before and at one, six, 12, 18 and 24 months post‐operatively INCLUSION CRITERIA: 1. Requirement of an elective permanent stoma due to bowel disease 2. Written informed consent 3. Must be aged 18 ‐100 years and agree to the randomised procedure 4. If of childbearing potential, must have given a negative pregnancy test