Stenting the ureteroneocystostomy reduces urological complications in kidney transplantation: a noninferiority randomized controlled trial, SPLINT trial

摘要

The role of ureteral stents in living-donor kidney transplantation remains uncertain. In this randomized controlled trial (SPLINT), we compared urological complications in living-donor kidney transplantations performed with or without stents. We included 200 consecutive patients that received living-donor kidney transplantations at the Erasmus MC, University Medical Center, Rotterdam. Patients (124 males, 76 females, mean age 54 +/- 13) were randomized for suprapubic externalized single J stents (N = 100) or no stent (N = 100). The primary outcome was the probability of a percutaneous nephrostomy insertion (PCN) during a 12-month follow-up. To assess whether no stenting is noninferior to stenting, we allowed the probability of a PCN to increase by at most 5% (this is the noninferiority margin). Baseline characteristics were comparable between groups. In the no-stent group, there were more PCN insertions, 14% (95% CI 4.3-23.7%); urinary leakages, 12% (95% CI 5.4-21.3%); and surgical re-interventions because of urological complications, 8% (95% CI 1.5-14.5%). The stent group had more hematuria, 26% (95% CI 13.1-38.9%); and graft rejections, 15% (95% CI 2.7-27.3%). Patients in both groups had similar mean GFRs at several time points. Besides a better Euro-Qol-5D in the no-stent group at 2 and 6 weeks postoperative, similar quality of life was reported based on SF-36 and Euro-Qol-5D scores. In this trial, noninferiority has not been demonstrated for no-stent placement in relation to the number urological complications.