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

Jwo 2010.

Methods

  • Study design: parallel RCT

  • Study time frame/recruitment period: December 2002 to October 2006

  • Follow‐up period: not reported
Participants

  • Country: Taiwan

  • Setting: single centre

  • All incident PD patients

  • Number: treatment group (37); control group (40)

  • Mean age ± SD (years): treatment group (56.7 ± 13.4); control group (54.4 ± 16.5)

  • Sex (M/F): treatment group (12/25); control group (18/22)

  • Diabetes: treatment group (17/37); control group (13/40)

  • Exclusion criteria: intolerant to spinal/general anaesthesia; unwilling to participate
Interventions Treatment group

  • Laparoscopic insertion of catheter

  • 500 mg of cefazolin, a prophylactic antibiotic, was given IV before anaesthesia.

  • Laparoscopic adhesiolysis was performed for those who had peritoneal adhesion due

  • to previous abdominal surgery or pelvic inflammatory disease.

  • The postoperative care of the laparoscopic group was identical to that of the open group.


Control group

  • Open surgical method of catheter insertion

  • 500 mg of cefazolin, a prophylactic antibiotic, was given IV before anaesthesia

  • No additional surgery such as omentectomy or salpingectomy was performed. PD was started at 7 d postoperatively
Outcomes

  • Patient survival

  • Catheter dropout

  • Early catheter‐related complication including catheter migration, leak, bleeding

  • Late catheter‐related complication including catheter migration, leak, exit‐site infection, peritonitis, hernia
Notes

  • Additional data requested from authors

  • Funding source:
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Insufficient information to permit judgement, significantly high number of cirrhosis patients in laparoscopic group
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 of follow‐up
Selective reporting (reporting bias) Low risk All the outcomes were reported
Other bias High risk Different baseline characteristic between the two groups