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. 2018 Jul 20;2018(7):CD008905. doi: 10.1002/14651858.CD008905.pub3

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)
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