Radiological versus surgical implantation of first catheter for peritoneal dialysis: a randomized non-inferiority trial.
BACKGROUND
The success of peritoneal dialysis (PD) is dependent on timely and adequate PD catheter access. In many centres, including our own, PD catheter insertion technique has evolved by laparoscopic surgery. An alternative method of catheter insertion is performed by radiologists using a percutaneous modified Seldinger technique under fluoroscopic guidance. However, there are no clinical trials comparing these two methods of catheter insertion.


METHODS
From 1 April 1999 to 30 August 2004, we randomly assigned 113 pre-dialysis patients to receive PD catheter insertion using fluoroscopic guidance under local anaesthesia by radiologists or insertion using laparoscopy under general anaesthesia by a surgeon. The primary endpoint was the occurrence of dialysis catheter complications (complication-free catheter survival) by Day 365, a composite endpoint that included complications secondary to mechanical and infectious causes. Secondary endpoints were the occurrence of catheter removal (overall catheter survival) and death from any cause (patient survival) by Day 365, procedure pain, procedure time, procedure room utilization time, length of inpatient admission and direct hospital costs. Results were analysed by univariate and multivariate methods and by Kaplan-Meier survival curves.


RESULTS
Complication-free catheter survival was significantly higher at 42.5% [95% confidence interval (CI) 29.3-55] in the radiological group compared with 18.1% (95% CI 8.9-29.8) in the laparoscopic group (P-value = 0.03). Excess complications in the laparoscopic group included peritonitis, peritoneal dialysate leaks and umbilical herniae. One-year overall catheter survival and 1-year subject survival were not different between the groups. Hospital costs were significantly higher in the laparoscopic group by almost a factor of two.


CONCLUSIONS
Radiological insertion of first PD catheters using fluoroscopy is a clinically non-inferior and cost-effective alternative to surgical laparoscopic insertion.
Department of Renal Medicine, Middlemore Hospital, Counties-Manukau District Health Board, Otahuhu, Auckland, New Zealand. dvoss@middlemore.co.nz
David
D
Voss
Stewart
S
Hawkins
Garth
G
Poole
Mark
M
Marshall
D000368:Aged; D002404:Catheterization / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D020878:Device Removal; D005260:Female; D005471:Fluoroscopy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000628:therapy*; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D010530:Peritoneal Dialysis / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D016019:Survival Analysis; D016896:Treatment Outcome