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. 2016 Jan 4;2016(1):CD002764. doi: 10.1002/14651858.CD002764.pub2

Fiori 2012.

Methods Prospective randomised trial
Participants 22 patients January 2003 to May 2003. Stage IV unresectable colorectal cancer with symptoms of subacute obstruction > 3 months
Interventions Colostomy 11/22; transanal self expandable metallic stent (SEMS) 11/22
Outcomes Oral feeding and bowel function: SEMS 100% 24 hours; colostomy 100% 96 hours
SEMS group further symptoms 27% (3/11): average 100 days from procedure; 2 patients had faecal impaction and 1 patient had re‐obstruction with tumour in‐growth
Colostomy group no further symptoms
SEMS group complications
Colostomy group complications: stoma prolapse: 9% (1/11), skin irritation 9% (1/11), anaemia requiring blood transfusion 18% (2/11)
Notes Patients and families complained the stoma significantly interfered with lifestyle; none of the patients who had stent placement complained about the procedure
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Patients were randomly assigned to 1 of the 2 forms of treatment according to random numbers table." Patients assigned to transanal self expanding metallic stent or diverting proximal colostomy
Allocation concealment (selection bias) High risk No blinding
Blinding (performance bias and detection bias) 
 All outcomes High risk Patients assigned to transanal self expanding metallic stent or diverting proximal colostomy
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Patients assigned to transanal self expanding metallic stent or diverting proximal colostomy
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No blinding
Selective reporting (reporting bias) Low risk All patient outcomes reported
Only one surgical procedure used