| Methods |
Randomised trial. Computerised randomisation |
| Participants |
52 (mean age control group = 67.3 +/‐ 13.6 years, intervention group = 70.5 +/‐ 9.5 years), Male 37:11 Female |
| Interventions |
Participants were randomised into a group undergoing placement of a flexible composite prosthetic mesh with a modified Sugarbaker technique at the time of surgery (n = 24) or to a control group (no mesh) (n = 28). |
| Outcomes |
Incidence of parastomal hernia at 12 months (CT detected) |
| Length of Follow Up |
Median follow‐up of the study was 26 months (range 13 to 38 months). |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated randomisation |
| Allocation concealment (selection bias) |
Low risk |
Allocation was concealed prior to surgery. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Comment: Not possible to blind the surgeon as to which procedure was being performed |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
The reporting radiologist assessing participant CT scans was blinded to the allocation. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
We identified no selective reporting. |
| Selective reporting (reporting bias) |
Low risk |
Comment: No evidence of reporting bias |
| Early Stopping |
Low risk |
Comment: No evidence of early stopping |
