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) |
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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 |