Jänes 2009.
Methods | Randomised trial. Envelope randomisation | |
Participants | 54 (mean age control group = 71 (67 to 76 years), invervention group = 70 (64 to 75 years)), Male 31:23 Female | |
Interventions | Participants received either a traditional end colostomy (n = 21) or had a Vypro mesh placed dorsal to the rectus abdominis muscle and anterior to the posterior rectal sheath (n = 15). | |
Outcomes | Development of parastomal hernia at 5 years from index surgery by clinical examination | |
Length of Follow Up | Mean 65.2 months (range 57 to 83 months) | |
Notes | Mortality data from Jänes 2009 were only available for a 12‐month follow‐up (Jänes 2004a), therefore subsequent data may not be relevant in the assessment of this review. 6 participants from the control group and 12 from the intervention group lost to follow‐up. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Comment: Participants were randomised using consecutively numbered, sealed envelopes. No random sequence generation |
Allocation concealment (selection bias) | Low risk | Quote: "consecutively numbered sealed envelopes" Comment: Probably occurred |
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 | Quote: "Patients were examined after 1 month, 12 months, and 5 years by an investigator blinded to the actual randomisation. They were then examined straining in both an erect and a supine position." Comment: Blinded outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Those lost to follow‐up were accounted for. |
Selective reporting (reporting bias) | Low risk | We identified no selective reporting. |
Early Stopping | Low risk | Comment: Sample size calculation was included. Trial was stopped early on ethical grounds due to statistical testing favouring the mesh. |