Open vs Laparoscopic CAPD catheter placement, a randomized controlled clinical trial

The patient population with end-stage renal disease dependent on dialysis is
increasing. This renal replacement therapy can take place in two different
ways: haemodialysis and peritoneal dialysis. Boths options have their patient
population in which a certain technique is more suitable. The present study
focusses on patients who will become dependent on peritoneal dialysis. To
facilitate this technique, a catheter has to be placed in the peritoneal cavity
in order to administer the dialsysate which has to be changed severel times a
day. A well-functioning catheter is of the utmost importance for the success of
this therapy. Several catheter complications, both infectious and
non-infectious, hamper the CAPD treatment. The infectious complications can be
subdivided into peritonitis, exit site infections and tunnel infections whereas
non-infectious complications can be subdivided into abdominal hernia, dialysis
leakage, obstruction of the catheter, adhesions in the peritoneal cavity and
catheter tip migration.
Clinical practivce reveals two different techniques by which the abdominal
catheter can be placed; the open procedure and the laparoscopic procedure.
Untill now, there is no agreement which technique results in more complications
and interventions and thus which technique has the potency to result in the
most optimal catheter functioning.

Primary Objective:
Determination of the best surgical approach in the individual patient to
achieve optimal outcome statistics (catheter survival, 30-day or in-hospital
mortality and long-term mortality)

Secondary Objective:
Comparison of short and long-term complications in patients who receive a
catheter for peritoneal dialysis by either open surgery or laparoscopic
surgery.

Multicenter randomized controlled clinical trial

Patients will be asked to participate in this study after screening for in- and
exclusion criteria by the surgeon. After the informed consent procedure
patients of both centers will be randomized by computer in either the
laparoscopic or the open surgical arm. During follow-up of the patient,
infectious and non-infectious complications will be monitored and overall
usability of the catheter will be evaluated.

Placement of a CAPD catheter either by an open or laparoscopic surgical
procedure. Both treatment options are part of regular patient care. Description
of the surgical procedure is available on page 9,10 and 11 in the study
protocol.

The burden on the patient doesn't change compared to current clinical practice.
The indication for the intervention will be set during a visit to the
pre-dialysis clinic by independant physisians. After this the patient will be
referred to the surgical out-patient clinic where the informed consent
procedure takes place. The patient is informed about the surgical procedures
and after informed consent the patient is randomised by computer in either the
open or the laparoscopic arm.
The surgeon is well trained and experienced in performing both procedures. The
follow-up of the patients will take place during regular follow-up on the
dialysis ward and thus extra visits to the clinic will not be necessairy.