| Methods |
Randomised trial. Envelope randomisation |
| Participants |
232 (mean age control group = 65.9 +/‐ 15.6 years, intervention group = 66.6 +/‐ 12.9 years), Male 135:97 Female |
| Interventions |
Conventional end colostomy (n = 118) vs end colostomy plus a lightweight polypropylene mesh (n = 114) |
| Outcomes |
Incidence of parastomal hernia at 12 months (CT and clinically detected). Early and late complications |
| Length of Follow Up |
12 months |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Sealed envelopes prepared by an outside institution |
| 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 |
Clinical postoperative assessment made by a surgeon not involved in the primary procedure. It was not clear if the reporting radiologists were also blinded to the procedure. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Transparent reporting of participants lost to follow‐up |
| Selective reporting (reporting bias) |
Low risk |
Comment: No evidence of reporting bias |
| Early Stopping |
Low risk |
Comment: No evidence of early stopping |
