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

Rubin 1990.

Methods
  • Study design: parallel RCT

  • Study time frame/recruitment period: May 1987 to September 1989

  • Follow‐up period: 2 years

Participants
  • Country: USA

  • Setting: single centre

  • All patients undergoing placement of initial PD catheters

  • Number: treatment group (50); control group (35)

  • Mean age ± SD (years): treatment group (47 ± 18); control group (51 ± 17)

  • Sex (M/F): 40/45

  • Diabetes: not reported

  • Exclusion criteria: previous abdominal surgery that precluded randomisation of catheter insertion site

Interventions Treatment group (groups 1 and 3)
  • Midline insertion, straight catheter/lateral insertion, straight catheter


Control group (groups 2 and 4)
  • Midline insertion, spiral catheter/lateral insertion, spiral catheter


Other information
  • All procedures performed in an operating room environment

  • Dialysis was started within 2 to 3 hours of returning from the operating theatre

Outcomes
  • Exit site/tunnel infection: tunnel infection ‐ obvious purulence from the catheter exit site in association with peritonitis; exit‐site infection ‐ purulence of exit site without peritonitis

  • Peritonitis: dialysate becoming turbid and abdominal pain or a positive culture

  • Catheter removal/replacement

Notes
  • 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 Unclear risk Insufficient information to permit judgement
Selective reporting (reporting bias) High risk Not all the outcomes were reported
Other bias High risk Introduced new type of catheter and new catheter insertion technique at the same time for the treatment group