This study compares the result of straight versus coiled Tenckhoff catheters for peritoneal dialysis patients. Recent meta-analysis of the peritoneal dialysis catheter type was in favor of straight catheters. The effects of straight versus coiled peritoneal dialysis catheters, however, are unclear. The investigators design an adequately powered randomized controlled study to evaluate the two types of double-cuffed peritoneal dialysis catheters. The primary objective is to assess whether straight peritoneal dialysis catheters can reduce the risk of catheter dysfunction that requires intervention. The investigators estimate that they would need to enroll 132 incident peritoneal dialysis patients in each group for the study to have 80% power to detect a difference between 7% and 15% in the primary endpoint of catheter dysfunction requiring intervention.
The objective of the present study is to evaluate the a priori hypothesis that straight peritoneal dialysis catheters would improve the treatment outcomes of peritoneal dialysis. The early and late catheter complications, as well as catheter survival, will be compared between peritoneal dialysis patients who are randomized to straight and coiled Tenckhoff catheters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
306
Peritoneal dialysis catheters for long term use
Prince of Wales Hospital, Chinese University of Hong Kong
Shatin, New Territories, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tai Po, Hong Kong
Incidence of catheter dysfunction that requires intervention
Catheter dysfunction refers to drainage failure, as defined by the inability to drain peritoneal dialysate effluent reliably within 45 minutes. Intervention includes catheter repositioning or reinsertion, either by open surgical method or laparoscopically
Time frame: One year
Time to catheter dysfunction requiring intervention
see above
Time frame: One year
Dialysis catheter migration with dysfunction
Dialysis catheter tip located above the pelvic brim on the abdominal radiograph
Time frame: One year
Infusion pain
Patient will be questioned on infusion pain around one month after starting peritoneal dialysis
Time frame: One month
Risk of peritonitis
Time frame: One year
Technique failure
Time frame: One year
Peritoneal dialysis catheter survival
Time frame: One year
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