Riapisarda 2006.
Methods | ‐Country: Italy
‐Setting: university hospital ‐Study design: RCT |
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Participants | ‐No. of participants randomised: 99
‐Age (mean): 67.1 years
‐Gender: 47 males, 52 females ‐Exclusions post randomisation: not specified ‐Shifted to another arm: In the Seldinger group conversion to the venous cutdown technique occurred in 3 participants. In the venous cutdown group conversion to the Seldinger technique occurred in 1 participant ‐Inclusion criteria: TIVAP implantation for administration of systemic chemotherapy for the treatment of neoplastic ‐Exclusion criteria: not specified |
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Interventions | A total of 99 participants were randomly assigned to the cephalic vein cutdown group or the Seldinger group with percutaneous puncture of the subclavian vein. (n = 49 in the cutdown group and n = 50 in the Seldinger group). Intraoperative fluoroscopy was used and final postprocedural chest radiograph to confirm final catheter position | |
Outcomes | ‐Technical failure requiring conversion to alternative technique ‐Mortality or associated morbidity ‐Early complications (within 30 days after implantation) ‐Late complications ‐Mean operation time ‐Operative cost ‐Patient acceptance |
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Notes | All participants underwent local anaesthetics with antibiotic prophylaxis with ceftriaxone. Only oncology patients |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as "randomized", but method not specified in the manuscript |
Allocation concealment (selection bias) | Unclear risk | Not specified in the manuscript |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | No blinding of either participants or personnel mentioned in the methodology. Comment: Blinding of personnel carrying out the procedure is not feasible for this procedure. Blinding of participants, however, is practically feasible. Nevertheless, it is unlikely the blinding of the personnel and participants would have affected the outcomes of the study. We judged performance bias as low risk of bias |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | High risk | Losses to follow‐up: not specified |
Selective reporting (reporting bias) | High risk | Outcomes not reported in methods section |
Other bias | High risk | No mention of funding. No mention of conflict of interest of authors. Exclusions post randomisation: not specified |