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. 2018 Jan 29;2018(1):CD011455. doi: 10.1002/14651858.CD011455.pub2

TrUST 2017.

Methods
  • Study design: parallel RCT; block‐stratified for age (2 to 16 years; 17 to 75 years)

  • Study duration: April 2010 to October 2013

  • Duration of follow‐up: minimum 6 months

Participants
  • Country: UK

  • Setting: multicentre (6)

  • Living and deceased donors; adult and paediatric ESKD recipients

  • Number (analysed/PP population): treatment group (80/81); control group (126/131)

  • Median age, IQR (years): treatment group (47.5, 31.1 to 58.0); control group (41.7, 24.2 to 53.8)

  • Sex (M/F): treatment group (54/27); control group (93/37)

  • Exclusion criteria: increased risk of bleeding; abnormal urinary tract anatomy or function; planned early use of mTORi; stones

Interventions Treatment group
  • Early removal group had a ureteric stent attached to the urethral catheter intraoperatively and then removed non‐invasively on day 5 to 7


Control group
  • Late removal group had a J‐J stent placed routinely intraoperatively and it was removed at approximately 6 weeks cystoscopically


Other information
  • Stent calibre: 6FR/16cm for adults, 4.8‐6Fr/16cm for children

  • Stent Type: Double J stent

  • Bladder catheter for 75 days

Outcomes
  • MUC (ureteric leaks, ureteric stenosis; "intermediate urological complications" i.e. oedema or clot causing obstruction that had to be managed by nephrostomy) (80 patients analysed in the early removal group)

  • UTI (79 patients in the early removal group analysed)

Notes
  • Study not powered to assess MUC

  • 15 cases of failure to tie catheter to stent due to technical difficulty

  • 21 patients in the early group failed to receive the allocated treatment and were regarded as crossovers into the late group, undergoing late stent removal

  • Investigated effect of early removal on idiosyncratic stent complications and QoL

  • Funding source: NIHR and Guy's and St Thomas' Charity

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Online computer generated randomisation process, block stratified with randomly varying block sizes
Allocation concealment (selection bias) Low risk Allocation revealed to clinicians at time of randomisation
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Blinding not possible but unlikely to affect outcome
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Not possible
Incomplete outcome data (attrition bias) 
 All outcomes Low risk CONSORT diagram included detailing full follow‐up
Selective reporting (reporting bias) Low risk All outcomes reported
Other bias Low risk The study appears to be free of other biases

BI ‐ bladder indwelling; CIT ‐ cold ischaemic time; DGF ‐ delayed graft function; DPTA ‐ diethylenetriaminepentaacetic acid; ESKD ‐ end‐stage kidney disease; IQR ‐ interquartile range; IV ‐ intravenous; M/F ‐ male/female; MSU ‐ midstream urine; mTORi ‐ mammalian target of rapamycin inhibitor; MUC ‐ major urological complications; PC ‐ percutaneous; PU ‐ per‐urethral; PP ‐ per protocol; RCT ‐ randomised controlled trial; SCr ‐ serum creatinine; SD ‐ standard deviation; USS ‐ urinary ultrasound; UTI ‐ urinary tract infection