| Methods |
Randomised trial, computer randomisation |
| Participants |
146 (mean age= 63) Male 92:58 Female |
| Interventions |
Placement of retromuscular lightweight polypropylene mesh around a colostomy vs no mesh |
| Outcomes |
After 12 months of follow‐up: incidence of parastomal herniation, operation time, postoperative morbidity, pain and quality of life |
| Length of Follow Up |
Maximum 12 months |
| Notes |
The PREVENT trial |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Participants were randomised by computer, and an interactive voice response system was used. |
| Allocation concealment (selection bias) |
Low risk |
Computerised randomisation |
| 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 |
High risk |
The assessment of the presence of PH is made through clinical examination. The authors state that CT scan assessment would be done on all suspected PH, but only 16 were performed. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
12 months' data were available with the full publication in 2016. 13 out of 150 participants not included in final analysis. |
| Selective reporting (reporting bias) |
Low risk |
Comment: No evidence of reporting bias. Complications well documented. |
| Early Stopping |
Low risk |
Comment: Sample size calculation given. No early stopping reported. |
