Prevention of urological complications in living kidney transplantation: stenting or not?

Kidney transplantation is the only treatment offering long-term benefit to
patients with chronic kidney failure. Urological complications after kidney
transplantation are associated with significant morbidity, mortality, prolonged
hospital stay and a radiological intervention or second surgical procedure is
frequently required. The majority of urological complications are related to
the ureteroneocystostomy and a first sign is often placement of a percutaneous
nephrostomy (PCN) drain1. It has been suggested that routine use of a
prophylactic ureteral stent (splint) in kidney transplantation may diminish the
risk of urological complications. However, the role of ureteral stents in
living donor kidney transplantation is not well defined and there is concern
about potential stent related complications as infection, obstruction, stent
migration, breakage, stone formation, haematuria, and secondary ureter
obstruction. Most surgeons make a choice based on their training, and not based
on specific rationale or literature. To date, 5 randomized controlled trials2-6
on stent placement have been reported; however, they differ in study design
concerning living or deceased donation, type of ureteroneocystostomy
anastomosis (intravesical or extravesical), type of stent and donor or
recipient characteristics. An advantage for stent placement is suggested, but
notably, in some studies on routine basis and in others on strictly defined
criteria. A meta-analysis7 on this topic supports the use of ureteral stents in
selected recipients, but without a statement on routine stenting, type of stent
and timing of stent removal8. In this study the hypothesis will be tested if
omitting a stent is at least as effective as the use of a stent or even reduces
urological complications, stent related complications, and PCN placements in
kidney transplantation.

Primary objective: To asses if stenting of the ureteroneocystostomy in living
kidney transplantation recipients is necessary to prevent urological
complications.

Secondary objective: To assess if stenting influences the total amount of
urological complications, radiological interventions, surgical interventions,
haematuria, and urinary tract infections. Stent obstructions or dysfunctions
will be scored. Additionally, a quality of life and cost effectiveness analysis
will be preformed with questionnaires. Validated questionnaires for quality of
life, health state, work efforts and disabilities in daily life are measured by
the Euro-Qol, SF-36 and *Werk en Zorg*. All questionnaires will be filled in
pre-operatively and post-operatively at different time points.

This will be a single-centre randomized controlled trial with a non-inferiority
design. Randomization will be performed after intubation in the operation room
by a envelop randomization system. All inclusions will be performed in 2 years,
100 recipients each year. Last follow-up moment of all questionnaires will be
after one year.

Nowadays, our clinical practice is the use of a stent in case of kidney
transplantations from a living kidney donation. Our *intervention* will be the
non-use of a stent. Alongside, we will ask the recipients to fill in a
questionnaire to analyse the quality of life and make a cost-effectiveness
analysis.

There is no additional risk for the patient or the operation. Patients in one
or the other group may have benefit, but only with this randomized controlled
trial we can identify the beneficial operation. As literature is inconclusive
according to stent use, we do not know the benefits.