Surgical technique for continuous ambulant peritoneal dialysis catheter insertion: Laparoscopic or open catheter insertion?

Almost 15.000 Dutch patients with end-stage renal disease (ESRD) are dependent
of renal replacement therapy (RRT; dialysis and transplantation). Of the nearly
6300 patients on dialysis, one fifth is on continuous ambulant peritoneal
dialysis (CAPD). It has an advantage over haemodialysis in that it allows
patients greater freedom to perform daily activities; it also provides other
clinical benefits, such as less dietary and fluid restriction, better blood
pressure control and less cardiovascular stress. Another advantage of CAPD over
haemodialysis is the costs. Annually, CAPD costs $43,000 dollars less than
haemodialysis, therefore well-functioning CAPD has major economic consequences.
The key to successful CAPD is the presence of a well-functioning dialysis
catheter, defined as one that facilitates free dialysis solution inflow and
outflow. However, we have noticed that CAPD catheter insertion has a high rate
of technical failure using the standard open technique and thus needs
improvement. The current literature describes a range from 10-35 % catheter
failure with the open technique. Catheter malfunction is most commonly caused
by mechanical complications, such as kinking or malpositioning of the catheter
tip. Complications frequently cause considerable problems for ESRD patients,
including re-operation and an increased risk of losing access to CAPD. For a
small but significant number of patients this leads to severe morbidity and
even mortality. Laparoscopic procedures have proven to be superior to a number
of open surgical procedures, by reducing morbidity, length of hospital stay,
postoperative pain and lead to a quicker convalescence. In contrast to the open
technique, laparoscopic insertion enables the surgeon to insert the
CAPD-catheter under direct vision using a video-laparoscope, and thus enables
him to ascertain the correct catheter position at the end of the operation. In
current literature, comparative trials show no significant difference in the
risk of catheter removal, replacement or technical failure between both
techniques, however there are no well-designed randomized controlled trial
comparing laparoscopic CAPD-catheter insertion to the traditional open
technique.

Primary Objective: Does the use of the laparoscopic insertion technique lower
the incidence of malfunctioning CAPD-catheters at 6 weeks postoperatively?
Secondary Objectives: Does the use of the laparoscopic insertion technique
improve catheter longevity and reduce the rate of surgical complications,
mortality, leakage, catheter migration, re-admissions, exit-site infections,
peritonitis and duration of hospital stay? Does the use of the laparoscopic
insertion technique reduce postoperative pain, the use of postoperative pain
medication and increase the quality of life? Does laparoscopic catheter
insertion influence peritoneal membrane function at 2 months postoperatively as
measured with peritoneal equilibration test?

A multicenter prospective single blinded randomized controlled trial. Duration
of the study will be 18 months.

Group 1: Laparoscopic catheter insertion
Group 2: Open catheter insertion

The burden and risks associated with participation is limited to one of the two
surgical techniques of CAPD-catheter placement. The number of blood samples,
the number of site visits and physical examinations is the same as in the
current standard protocol. One additional X-ray image of the abdomen will be
done in all patients at day one and six months postoperatively. Abdominal x-ray
is necessary to identify catheter position or migration. Participants are asked
to fill out a quality of life questionnaire before surgery and at week 4, 6, 8,
12 and 26 postoperatively. Participants are asked to give a pain score using
the visual analogue scale at day 0, 1, 2, 3, 7 and 14 postoperatively and fill
out the EuroQol questionnaire preoperatively and at day 3 and week 1, 2, 4, 12,
26.