| Objective: |
Pragmatic, prospective phase III, multi-centre randomised clinical trial to determine if the use of a collagen tissue matrix/biological mesh reduces the incidence of clinically detectable stoma closure site hernias at two years as compared to standard closure techniques. |
| Aim: |
PRIMARY OBJECTIVE Assess herniation rates detected by clinical examination at two years post randomisation. SECONDARY OBJECTIVES Assess radiological hernia rates at one year post randomisation. Assess surgical re-intervention rates. Assess the frequency of wound infections and seroma associated with the mesh. Assess the impact of the mesh on a patient?s quality of life and any pain experienced. Quality of life an important secondary outcome measure, as the re-operation rate may be low, as even if a clinical hernia is diagnosed, the decision for surgical re-intervention has to take into account the patient?s age, any co-morbidities and patient preference. Determine the cost effectiveness of the mesh insertion in stoma site closure and management of subsequent hernias. Conduct an exploratory analysis to investigate the CT scan as an early surrogate marker of late clinical herniation. Radiological hernia rate at one year post randomisation will be compared with the clinical hernia rate at two years to assess the value of using a CT scan as an early diagnostic tool of herniation. This will identify to other investigators that this is a potential area of clinical need and allow earlier reporting of future studies. |
| Methods: |
Patients undergoing elective closure of the stoma site will be randomised in a 1:1 ratio between: 1) Stoma closure site reinforcement using the biological mesh Vs. 2) Control - standard closure without mesh A minimisation procedure using a computer-based algorithm was used to avoid chance imbalances in important prognostic variables. The minimisation variables were: 1. Stoma type ileostomy versus colostomy. 2. Surgical incision - reopening of midline wound or stoma site only. 3. Skin closure type ? primary or secondary. The original sample size was increase from 560 to 790, which improve the statistical power from 80% to 90%. The trial is looking for a 40% proportional reduction in herniation (25% to 15%). The eligibly requirements for participation in the trial were: ? Inclusion Criteria o Required an elective closure of an ileostomy or a colostomy. o Abel and willing to provide written informed consent for the study. o Aged 18 years or over. ? Exclusion Criteria o Taking part in another clinical study which is related to the surgical procedure. o Allergic to any porcine or collagen products. o Unable or unwilling to provide written informed consent. o History of familial adenomatous polyposis. o Surgeon determined that a mesh repair was definitely required e.g. due to large parastomal hernia. |
| Reason for International Trial: |
To establish an international network that will be utilised for future trials. |