Lopez‐Cano 2012.
Methods | Randomised trial. Computerised randomisation | |
Participants | 36 (mean age control group = 66 +/‐ 13.9 years, intervention group = 72 +/‐ 7.6 years), Male 18:18 Female | |
Interventions | Participants were randomised into a group undergoing placement of a large‐pore lightweight mesh in the intraperitoneal/onlay position at the time of surgery (n = 19) or to a control group (no mesh) (n = 17). | |
Outcomes | Incidence of parastomal hernia at 12 months (CT detected) and subcutaneous fat thickness at 12 months (CT measured) | |
Length of Follow Up | 12 months | |
Notes | 1 participant from the control group and 1 participant from the intervention group were lost to follow‐up. | |
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 | 8 of the 44 randomised participants were not included in the final analysis. Comment: Clear explanation of incomplete follow‐up data |
Selective reporting (reporting bias) | Low risk | We identified no selective reporting. |
Early Stopping | Low risk | Comment: Sample size calculation included. No evidence of early stopping |