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

Al‐Hwiesh 2016.

Methods
  • Study design: parallel RCT

  • Study time frame/recruitment period: December 2012 to June 2014

  • Follow‐up period: 18 months

Participants
  • Country: Saudi Arabia

  • Setting: single centre

  • Incident PD patient followed up in the study unit

  • Number: treatment group (36); control group (37)

  • Median age, IQR (years): treatment group (54, 42 to 63); control group (50, 45 to 61)

  • Sex (M/F): treatment group (11/25); control group (11/26)

  • Diabetes: treatment group (21/36); control group (23/37)

  • Exclusion criteria: previous abdominal or pelvic surgery; history of peritonitis; pregnancy

Interventions Treatment group
  • Triple cuff


Control group
  • Double cuff


Other information
  • Antibiotic prophylaxis with first generation cephalosporin was given IV prior to the procedure. APD was instituted 14 days after PD catheter insertion

Outcomes
  • Exit‐site, wound and tunnel infection

  • Peritonitis

  • Mechanical complications: bowel perforation, haemorrhage, poor drainage, omental wrapping, catheter migration, early leak, catheter replacement

  • Technique survival

Notes
  • Additional data requested from authors: yes

  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomised using adaptive randomisation method
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
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