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

Li 2009e.

Methods
  • Study design: parallel RCT

  • Study time frame/recruitment period: May 2005 to January 2006

  • Follow‐up period: 31.8 patient‐year for treatment group and 20.7 patient‐year for control group

Participants
  • Country: China

  • Setting: single centre

  • All PD patients entering the PD program

  • Number: treatment group (20); control group (19)

  • Mean age ± SD (years): treatment group (57.8 ± 15.7); control group (61.0 ± 19.4)

  • Sex (M/F): treatment group (10/10); control group (11/8)

  • Diabetes: not reported

  • Exclusion criteria: not reported

Interventions Treatment group
  • Double‐cuff straight‐tip Tenckhoff catheter with an artificial subcutaneous swan‐neck


Control group
  • Conventional double‐cuff straight‐tip swan‐neck catheter

Outcomes
  • Exit‐site infection rate

  • Peritonitis

  • Catheter‐related complication including catheter migration, outflow failure, surgery ‐related bleeding

Notes
  • Funding source: none

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomising chart
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
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 All patients were followed up and analysed
Selective reporting (reporting bias) Low risk All outcomes were reported
Other bias High risk Procedures were performed by 3 nephrologists; the study was terminated earlier than planned as they ran out of catheters