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

Akyol 1990.

Methods

  • Study design: parallel RCT; randomly allocated at time of surgery

  • Study time frame/recruitment period: October 1986 to July 1987

  • Follow‐up period: 72 weeks
Participants

  • Country: Scotland

  • Setting: single centre

  • Consecutive patients for CAPD

  • Number (catheters/patients): treatment group (20/20); control group (20/19)

  • Mean age, range (years): treatment group (49, 22 to 70); control group (45, 19 to 73)

  • Sex (M/F): treatment group (15/5); control group (8/11)

  • Diabetes: treatment group (3/20); control group (2/19)

  • Exclusion criteria: not reported
Interventions Treatment group

  • Straight tip


Control group

  • Coiled tip


Other information

  • All catheters were double‐cuff Tenckhoff with 4 cm (curled) and 5 cm (straight) between cuffs

  • 1g vancomycin by IV infusion preoperatively on day of surgery. Catheters inserted in an operating theatre with general or local anaesthetic
Outcomes

  • Exit‐site, wound and tunnel infection: defined as isolation of a pathogenic organism on culture in the presence of local signs of inflammation or infection i.e. swelling, redness, pain or discharge of any nature

  • Peritonitis: defined as either a positive culture form dialysis effluent or a WCC > 100/mm³ in the effluent associated with clinical evidence of peritonitis

  • Mechanical complications
Notes

  • Follow‐up terminated at the date of catheter removal or at the last clinic visit before the analysis

  • 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 Low risk Quote " Neither the patients nor the staff supervising their care thereafter were aware of the type of catheter used."
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 5% dropout (2/40)
Selective reporting (reporting bias) High risk Not all the outcomes were reported
Other bias Unclear risk Insufficient information to permit judgement