Transplant Trial Watch

Stenting the ureteroneocystostomy reduces urological complications in kidney transplantation: a non-inferiority randomized controlled trial, SPLINT-trial.

Ooms, L. S. S., et al.

Transplant International 2020 [record in progress].


Aims
The aim of this study was to investigate whether omitting a ureteral stent in living-donor kidney transplantation is as effective as stenting, and to compare urological complications resulting from these two procedures.

Interventions
Participants were randomly assigned to either the stent group or the no-stent group.

Participants
200 living-donor kidney transplant recipients.

Outcomes
The primary endpoint was the insertion of a percutaneous nephrostomy (PCN) within 12 months. The secondary endpoints were graft function (measured as glomerular filtration rate (GFR)), length of surgery, duration of hospital stay, perioperative blood loss, any surgical re-intervention performed within less than 12 months post-transplant, urinary tract infection (UTI), hematuria, and graft rejection <1 month following renal transplantation.

Follow-up
12 months

CET Conclusions
This is a good quality RCT from a single centre in the Netherlands, including 200 recipients of live donor renal transplant. The study was randomised, but could not be blinded as the stent is externalised in the study arm. Analysis was by intention to treat. The control group (no stent) had significantly more urine leaks, nephrostomy insertions and surgical re-interventions. The study group (stent) had significantly higher rates of haematuria. Interestingly the study group also had a significantly higher rate of acute rejection, which is not easily explained. The external stent used for this trial is different from a double-J stent and the authors acknowledge that it is probably less commonly used. Despite this fact, the study supports stenting of the uretero-vesical anastomosis to reduce major urological complications after renal transplantation.

Jadad score
2

Data analysis
Available case analysis

Allocation concealment
Yes

Trial registration
Trial NL4358 (NTR4498)

Funding source
Non-industry funded