Skip to main content
. 2019 May 31;2019(5):CD004680. doi: 10.1002/14651858.CD004680.pub3

Ejlersen 1990.

Methods

  • Study design: parallel RCT

  • Study time frame/recruitment period: 1 June 1986 to 1 April 1988

  • Follow‐up period: 450 days
Participants

  • Country: Denmark

  • Setting: Single centre

  • All patients with chronic uraemia requiring the insertion of a permanent PD catheter for future CAPD

  • Number: treatment group (16); control group (21)

  • Median, range (years): treatment group (57, 28 to 74); control group (58, 28 to 75)

  • Sex (M/F): treatment group (9/7); control group (10/11)

  • Diabetes: not reported

  • Exclusion criteria: no prior history of extensive peritoneal adherences requiring laparotomy
Interventions Treatment group

  • Lateral insertion


Control group

  • Midline insertion


Other information

  • Catheter insertions performed by a senior registrar in urology.

  • Right‐angled modified Tenckhoff catheter, single‐cuff L‐catheter

  • Local anaesthetic used for both techniques

  • IV antibiotic prophylaxis just prior to procedure using 2g ampicillin or 2g cefalothin if penicillin allergy suspected

  • CAPD was not initiated until at least 2 weeks after insertion. Patients placed on intermittent PD or HD
Outcomes

  • Death

  • Peritonitis

  • Tunnel infection

  • Surgical/mechanical failure
Notes

  • Stop/end‐points: surgical or mechanical catheter failure requiring catheter removal: incurable peri‐catheter leakage, irreversible displacement and malfunction, peri‐catheter herniation

  • Funding source: The statistical support from the Danish Medical Research Council is acknowledged (J.no. 5.52.16.90.)
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 Unclear risk Not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No dropouts
Selective reporting (reporting bias) Low risk Most outcomes were reported
Other bias Unclear risk Insufficient information to permit judgement