Hammond 2008.
Methods | Randomised trial. Envelope randomisation | |
Participants | 20 (mean age control = 50 years (22 to 70 years), mean age intervention = 43 (21 to 69 years)), Male 7:13 Female | |
Interventions | Conventional loop ileostomy via a trephine incision (n = 10) vs loop ileostomy with a 10 x 10 cm Permacol mesh with a 2‐centimetre cylindrical defect cut in the centre (n = 10) | |
Outcomes | The incidence of parastomal hernia was assessed by ultrasound scan (16 of 20 trial participants). Incidence of infection and seroma assessed by laboratory tests and ultrasound scan. Incidence of patient symptoms assessed by a questionnaire. | |
Length of Follow Up | Maximum 12 months (if no reversal) Maximum 6.5 months (if stoma reversed) |
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Notes | No participants 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 | High risk | Quote: "underwent a clinical examination for signs of a parastomal hernia" Comment: No evidence of assessor blinding when performing clinical examination |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants lost to follow‐up. No complete 12‐month data. Appropriately outlined follow‐up regimen |
Selective reporting (reporting bias) | Low risk | Quote: "Patients were followed‐up until the time of stoma reversal or, in the event of the stoma not being reversed, until 12 months after stoma formation." Comment: No selective reporting. All participants and outcomes accounted for. |
Early Stopping | Low risk | No early stopping |