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

Nielsen 1995.

Methods

  • Study design: parallel RCT

  • Study time frame/recruitment period: April 1992 to July 1993

  • Follow‐up period: 15 months
Participants

  • Country: Denmark

  • Setting: single centre

  • Consecutive patients selected for CAPD programme

  • Number: treatment group (38); control group (34)

  • Mean age, range (years): treatment group (50, 18 to 79); control group (55, 29 to 78)

  • Sex (M/F): treatment group (20/18); control group (20/14)

  • Diabetes: treatment group (7/38); control group (6/34)

  • Exclusion criteria: not reported
Interventions Treatment group

  • Straight single cuff Tenckhoff


Control group

  • Coiled single cuff Tenckhoff


Other information

  • Catheters inserted by 5 nephrologists. All patients received premedication of a minor tranquillizer and morphine. Local anaesthesia used in all cases (lidocaine 1% containing norepinephrine)

  • Immediately after implantation, low volume (1 L) supine intermittent PD was initiated for 24 h (60 L) and continued 1 day/week for the first 3 to 4 weeks after implantation

  • All patients started on a disconnect CAPD system
Outcomes

  • Drainage failure

  • Tunnel or exit‐site infection: defined clinically as an inflammation with or without discharge

  • Peritonitis: two of four of the following: cloudy effluent; abdominal pain; leucocyte count > 100 x 106/L (> 50% neutrophils); positive culture
Notes

  • Stop or end points: results analyses after 60 patients and due to significant difference in catheter outcome, the study was terminated after the inclusion of 72 patients

  • Funding source: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study described as randomised; method of randomisation not reported
Allocation concealment (selection bias) Low risk Sequentially number sealed envelopes with catheter type in random order
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Both participants and personnel are blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk High dropout rate (32/72)
Selective reporting (reporting bias) High risk Not all the outcomes were reported
Other bias Unclear risk Insufficient information to permit judgement