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. 2019 May 31;2019(5):CD004680. doi: 10.1002/14651858.CD004680.pub3

Stegmayr 2015.

Methods
  • Study design: parallel RCT

  • Study time frame/recruitment period: February 2007 to June 2013

  • Follow‐up period: median follow‐up was 10 months (range 1 to 76 months; mean 15 ± 17 months)

Participants
  • Country: Sweden

  • Setting: single centre

  • All patients accepted for PD by physician

  • Number: treatment group (29); control group (32)

  • Mean age ± SD (years): treatment group (58 ± 13); control group (60 ± 18)

  • Sex (M/F): treatment group (20/9); control group (17/15)

  • Diabetes: treatment group (7/29); control group (12/32)

  • Exclusion criteria: once the patient was accepted for PD by the physician in charge there were no exclusion criteria for randomisation

Interventions Treatment group
  • Double cuffed Wolfram self‐locating catheter


Control group
  • Double cuffed Tenckhoff catheter

Outcomes
  • Catheter outflow failure

  • Early and late leak

  • Death

Notes
  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "A peritoneal dialysis nurse made randomization from envelopes and provided the surgeon with the respective catheter"
Allocation concealment (selection bias) Unclear risk Quote: "A peritoneal dialysis nurse made randomization from envelopes and provided the surgeon with the respective catheter"
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk High dropout; loss to follow‐up: died (7/61), transfer to HD (20/61), transplant (15/61)
Selective reporting (reporting bias) High risk Not all the outcomes were reported
Other bias Unclear risk Significantly large number of patients from treatment group dropped out due to transplant