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

Gadallah 1999.

Methods
  • Study design: parallel quasi‐RCT

  • Study time frame/recruitment period: October 1992 to October 1995

  • Follow‐up period: 3 years

Participants
  • Country: USA

  • Setting: single centre

  • Patients undergoing PD catheter placement (no further details)

  • Number: treatment group (76); control group (72)

  • Mean age ± SD (years): treatment group (45.0 ± 1.8); control group (47.2 ± 2.4)

  • Sex (M/F): treatment group (37/39); control group (22/34)

  • Diabetes: not reported

  • Race (White/Black/Latino): treatment group (25/50/1); control group (17/55/0)

  • Exclusion criteria: not reported

Interventions Treatment group
  • Peritoneoscopic placement

  • Performed by the same 3 nephrologists in a special procedure room under local anaesthesia and sterile conditions


Control group
  • Surgical placement

  • Performed by the same 3 surgeons in the operating room under general anaesthetic


Other information
  • Both groups received 1g vancomycin IV preoperatively

  • Postoperatively both groups had daily irrigation with 200 ml 1.5% dianeal and dialysis was not study until 1 week from the date of surgery

Outcomes
  • Early complications

  • Late complications

  • Catheter failure

  • Death

  • Peritonitis

  • Exit site/tunnel infection

Notes
  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Randomisation method was by alternate months, quasi‐RCT
Allocation concealment (selection bias) High risk Alternate months
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 3% dropout (5/148)
Selective reporting (reporting bias) Low risk All outcomes were reported
Other bias Unclear risk Insufficient information to permit judgement