Laparoscopic versus open peritoneal dialysis catheter insertion, the LOCI-trial: a study protocol

The LOCI-trial is a multi-center randomized controlled, single-blind trial (pilot). The study compares the laparoscopic with the open technique for PD catheter insertion. The primary objective is to determine the optimum placement technique in order to minimize the incidence of catheter malfunction at 6 weeks postoperatively. Secondary objectives are to determine the best approach to optimize catheter function and to study the quality of life at 6 months postoperatively comparing the two operative techniques.This study will generate evidence on any benefits of laparoscopic versus open PD catheter insertion.Dutch Trial Register NTR2878Approximately 15.000 patients in the Netherlands are diagnosed with end-stage renal disease (ESRD) and are dependent on renal replacement therapy (peritoneal dialysis, haemodialysis or transplantation). Almost 6.300 patients are on dialysis. One fifth is on peritoneal dialysis (PD). PD has several advantages over haemodialysis (HD): it allows patients greater freedom to perform daily activities, it requires fewer dietary restriction, and mortality is lower during the first two years of treatment [1]. The costs may also be of great importance. PD costs up to $43K dollars less than HD per person per year, therefore well-functioning PD may have major economic consequences [2,3]. However, we have noticed that PD catheter insertion has a high rate of technical failure using the standard open technique. Case-series report up to 35% catheter failure with the open technique [4-9]. Catheter malfunction is most commonly caused by complications, such as malpositioning of the catheter tip, in- and outflow obstruction, peritonitis, exit-site infections and leakage. These complications often lead to re-operation and even loss of PD as dialysis modality. For a small but significant number of patients this results in severe morbidity and even mortality. For many other surgical procedures, laparoscopy has proven to be superior to the open techniques, by