Comparison of functional outcome of PD catheters in the two placement techniques.Describing 30 day mortality and short and middle term complications.
ID
Source
Brief title
Condition
- Other condition
- Nephropathies
- Vascular therapeutic procedures
Synonym
Health condition
nierfunctie stoornissen waarvoor peritoneaal dialyse
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Functional outcome of the PD catheter.
Secondary outcome
30 day mortality
Short and middle term complications
Background summary
The patient population with end-stage renal disease dependent on dialysis is
increasing. This renal replacement therapy can be haemodialysis or peritoneal
dialysis. Boths options have selected indications. The present study focusses
on patients starting peritoneal dialysis. To facilitate this technique, a
catheter has to be placed in the peritoneal cavityto facilitate unobstructed
in- and outflow of dialysate multiple times a day. An adequate functioning
catheter is essential. Several infectious and non-infectious complications can
hamper peritoneal dialysis. Obstruction and dislocation of the catheter are
described to be influenced by surgical placement technique. There are different
methods of catheter placement but nowadays laparoscopic placement is preferred.
From previous research as the CAPD I trial we know that g=failure rates up to
30 % are seen.
In literature, beneficial outcome is seen with advanced laparoscopic techniques
and fixation of catheter and omentum.
No randomised trial comparing laparoscopic techniques with advanced
laparoscopy have been described so far. This trial will compare the functional
outcome of the PD catheter in both techniques and describe short and median
term complications.
Study objective
Comparison of functional outcome of PD catheters in the two placement
techniques.
Describing 30 day mortality and short and middle term complications.
Study design
Multicenter randomized controlled clinical trial.
Intervention
Laparoscopic PD catheter placement versus laparoscopic catheter placement with
fixation of catheter and omentum. Both treatment options are part of regular
patient care.
Study burden and risks
The burden for the patient is not different in the study than in standard care.
Both surgical techniques are performed by experienced surgeons.The techniques
are already routinely performed.
Hospital admission and follow up are the same.
P. DeByelaan 25
Maastricht 6229 HX
NL
P. DeByelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
• Age >= 18 years old
• End stage renal disease
• Suitable for CAPD catheter placement by laparoscopic technique
• Informed consent
Exclusion criteria
• No informed consent
• Malignancies
• Other intervention during the same surgical procedure not related to PD
placement in the abdominal cavity
• Loss of peritoneal function
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | 28868 |
CCMO | NL66424.068.18 |