|- candidate number||9403|
|- NTR Number||NTR2878|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-apr-2011|
|- Secondary IDs||NL34769.078.11 CCMO|
|- Public Title||Inbrengen van continue ambulante peritoneaal dialyse catheters: Kijkoperatie of open techniek?
|- Scientific Title||Surgical technique for continuous ambulant peritoneal dialysis catheter insertion: Laparoscopic or Open Catheter Insertion?|
|- hypothesis||The use of the laparoscopic insertion technique will lower the proportion of malfunctioning PD-catheters.|
|- Healt Condition(s) or Problem(s) studied||Laparoscopy, Open surgery, Peritoneal dialysis, End-stage renal disease|
|- Inclusion criteria||1. All patients with an indication for peritoneal dialysis;|
2. 18 years and older.
|- Exclusion criteria||1. BMI >35 kg/m2;|
2. Severe COPD (or otherwise not able to withstand laparoscopic surgery);
3. Age <18 years.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||16-mei-2011|
|- planned closingdate||15-mei-2013|
|- Target number of participants||100|
|- Interventions||1. Laparoscopic PD catheter insertion;|
2. Open PD catheter insertion.
|- Primary outcome||Percentage of functioning catheters at 6 weeks postoperatively.|
|- Secondary outcome||1. Surgical complications;|
2. PD complications;
3. Pain score;
4. Quality of Life;
6. Catheter survival.
|- Timepoints||1. Baseline;|
2. 6 weeks;
3. 6 months.
|- Trial web site||www.locitrial.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. S.M. Hagen|
|- CONTACT for SCIENTIFIC QUERIES||Dr. F.J.M.F. Dor|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Brief summary||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. |
|- Main changes (audit trail)|
|- RECORD||30-apr-2011 - 18-mei-2011|