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

Johnson 2006.

Methods
  • Study design: parallel RCT

  • Study time frame/recruitment period: February 2003 to February 2006

  • Follow‐up period: All patients were followed up until death, kidney transplantation, completion of PD therapy, or the end of the study on 24 March 2006, whichever came first

Participants
  • Country: Australia

  • Setting: multicentre (2 sites)

  • Adults patients with ESKD (stage 5 CKD) who required insertion of a Tenckhoff catheter for PD

  • Number: treatment group (70); control group (62)

  • Mean age ± SD (years): treatment group (56.3 ± 15.7); control group (57.6 ± 15.7)

  • Sex (M/F): treatment group (40/30); control group (42/30)

  • Diabetes: treatment group (29/70); control group (19/62)

  • Exclusion criteria: history of psychological illness or condition that interfered with the ability to understand or comply with requirements of the study

Interventions Treatment group
  • Straight Tenckhoff catheter


Control group
  • Coiled Tenckhoff catheter

Outcomes
  • Catheter malposition

  • Catheter associated infection (peritonitis, exit‐site infection)

  • Technique failure

  • Death (all causes)

Notes
  • Stop of end points: all patients were followed up until death, kidney transplantation, completion of PD therapy, or the end of the study on March 24, 2006, whichever came first

  • Funding source: none

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random number list with randomisation blocks of 20
Allocation concealment (selection bias) Low risk Random number with randomisation blocks of 20
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 Low risk No dropouts
Selective reporting (reporting bias) Low risk Low risk, most outcomes were reported
Other bias High risk Unequal baseline characteristics