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

Yip 2010.

Methods
  • Study design: parallel RCT

  • Study time frame/recruitment period: January 2001 onward

  • Follow‐up period: 24 month, mean duration of follow‐up was 18.9 ± 8.0 months

Participants
  • Country: Hong Kong, China

  • Setting: single centre

  • New patients entering chronic PD program

  • Number: treatment group (50); control group (51)

  • Mean age ± SD (years): treatment group (61.5 ± 14.9); control group (64.3 ± 13.7)

  • Sex (M/F): treatment group (30/20); control group (28/23)

  • Diabetes: not reported

  • Exclusion criteria: previous PD; patients requiring laparoscopic implantation of the PD catheter

Interventions Treatment group
  • Conventional double‐cuffed Tenckhoff catheter with straight tunnel which was converted to an arcuate one using the triple incision method resulting in a downward directed exit


Control group
  • Swan neck catheter

Outcomes
  • Complications including leakage, wound bleeding, wound infection, catheter malposition

  • Exit‐site infection and peritonitis

  • Death (all causes)

Notes
  • The study end point was removal of the catheter or 24 months after implantation, whichever was earlier

  • Additional data requested from authors

  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Not blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Low dropout rate (6/101)
Selective reporting (reporting bias) Low risk All the outcomes were reported
Other bias Unclear risk No prophylactic antibiotic for exit site. The study reported the procedures were performed by trained nephrologists in the unit, but unclear about the grade and training experience of the procedurists