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

Voss 2012.

Methods

  • Study design: parallel RCT

  • Study time frame/recruitment period: April 1999 to August 2004

  • Follow‐up period: 12 months
Participants

  • Country: New Zealand

  • Setting: multicentre (within the Counties‐Manukau District Health Board, Auckland, New Zealand)

  • Patients planned for PD; ≥ 18 years; suitable for both laparoscopic and radiological PD catheter insertions

  • Number: treatment group (57); control group (56)

  • Mean age, range (years): treatment group (61.1, 53.3 to 71.4); control group (60.8, 51 to 69.7)

  • Sex (M/F): treatment group (28/29); control group (30/26)

  • Diabetes: treatment group (30/57); control group (28/56)

  • Exclusion criteria: severe obesity (BMI > 35); previous abdominal surgery; history consistent with adhesions; severe medical comorbidity precluding general anaesthesia; bleeding diatheses; anticoagulation; HIV infection; ongoing corticosteroid or immunosuppressant use; severe psychiatric disease; definite plans for live donor kidney transplantation
Interventions Treatment group

  • Percutaneous insertion by radiologists using a modified Seldinger technique under fluoroscopic guidance


Control group

  • Laparoscopic insertion by surgeons under direct vision
Outcomes

  • Complication‐free catheter survival

  • Complications secondary to mechanical causes (insertion failure, patency failure defined as an inadequate inflow/outflow, hernia, dialysate leak or an abdominal hernia)

  • PD related peritonitis, exit‐site infection, catheter tunnel infection
Notes

  • Funding source: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote "allocated by simple randomization... performed by the research staff not involved with the care of the subjects"
Allocation concealment (selection bias) Low risk Sequentially numbered opaque, sealed envelopes
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 No dropouts
Selective reporting (reporting bias) Low risk Not all the outcomes were reported
Other bias Unclear risk Insufficient information to permit judgement