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

Zhang 2016.

Methods

  • Study design: parallel RCT

  • Study time frame/recruitment period: January 2013 to December 2015

  • Follow‐up period: 6 months
Participants

  • Country: China

  • Setting: single centre

  • ESKD patients required RRT

  • Number: treatment group 1 (49); treatment group 2 (54); control group (49)

  • Mean age ± SD (years): treatment group 1 (55.9 ± 17.1); treatment group 2 (57.2 ± 16.6); control group (53.8 ± 19)

  • Sex (M/F): treatment group 1 (32/17); treatment group 2 (29/25); control group (31/18)

  • Diabetes: treatment group 1 (12/49); treatment group 2 (11/54); control group (13/49)

  • Exclusion criteria: contraindications for PD or refuse to choose PD
Interventions Treatment group 1

  • Modified open surgery group

  • Lower position of catheter implantation; shorter length of intra‐abdominal catheter section which was set during operation based on a real‐time measurement of the distance between the peritoneal opening and the Douglas or rectovesical pouch


Treatment group 2

  • Modified open surgery with catheter fixation group


Control group

  • Traditional open surgery group
Outcomes

  • Catheter malfunction: defined as insufficient inflow and/or outflow of dialysate, including catheter tip migration and non‐migration problems, mainly refractory obstruction

  • Peritonitis, exit‐site and tunnel infections

  • Bleeding, leakage, inflow or outflow pain, hernia and delayed wound healing
Notes

  • Funding source: "This work was supported by The National Natural Science Foundation of China (81500537)"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random number table
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 All the outcomes were reported
Other bias High risk Percentage of patients with pervious abdominal surgery was appear to be higher than the other two modified surgery group (20.4% versus 10.2% and 13.0%)