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

Merrikhi 2014.

Methods
  • Study design: parallel RCT

  • Study time frame/recruitment period: 2010 to 2011

  • Follow‐up period: 2 months

Participants
  • Country: Iran

  • Setting: single centre

  • Patients < 15 years who will be receiving PD and have family support

  • Number: treatment group (18); control group (17)

  • Mean age ± SD (years): treatment group (6.77 ± 4.87); control group (6.38 ± 4.91)

  • Sex (M/F): treatment group (9/9); control group (12/5)

  • Diabetes: not reported

  • Exclusion criteria: history of prior major abdominal surgery; ventral or inguinal hernia; BMI ≥ 35 kg/m2

Interventions Treatment group
  • Percutaneous placement by 1 cm transverse incision on the skin just below the umbilicus


Control group
  • Open placement by making a left 3to 4 cm paramedian incision approximately 1 to 2 cm superior to the umbilicus

Outcomes
  • Catheter‐related infection: peritonitis, exit‐site infection

  • Mechanical complication of catheter

  • Outflow failure of catheter

Notes
  • Funding source: not reported

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 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 loss to follow‐up
Selective reporting (reporting bias) Low risk Study was registered with Iranian Registry of clinical trials
Other bias Unclear risk Insufficient information to permit judgement