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

Indu 2012.

Methods
  • Study design: parallel RCT of 100 consecutive patients

  • Study duration: January 2007 and December 2009

  • Duration of follow‐up: 6 months minimum

Participants
  • Country: India

  • Setting: single centre

  • Living donor kidney transplant (laparoscopic donor nephrectomy) for ESKD

  • Number: treatment group (50); control group (50)

  • Mean age ± SD (years): treatment group (34.4 ± 10.5); control group (33.8 ± 10.4)

  • Sex (M/F): treatment group (38/12); control group (40/10)

  • Exclusion criteria: if within 7 days patient developed urine leak, DGF or rejection prior to randomisation on day

Interventions Treatment group
  • Early removal at day 7 post‐op


Control group
  • Late removal at day 28 post‐op


Other information
  • Stent calibre: 4Fr 16cm

  • Stent type: double J, BI

  • Removal: flexible cystoscopy, local anaesthetic and IV ceftazidime for antimicrobial cover

  • Urinary catheter removed day 6

Outcomes
  • UTI

  • Asymptomatic bacteriuria

  • MUC

  • MSU sent routinely on day 7, at 3 weeks, 3 months and 6 months and at any other time if symptomatic

  • USS routinely performed on day 5, 4 weeks, 3 months and 6 months or if there was a rise in SCr

  • DTPA renogram routinely on day 5 and 6 months post‐op

Notes
  • Funding source: nil

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised by computer generated random numbers created by study coordinator
Allocation concealment (selection bias) Low risk Allocation kept in sealed opaque envelopes until opened on day 7 by ward nurses
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk No blinding but unlikely to impact outcome
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing outcome data, however CONSORT diagram not included
Selective reporting (reporting bias) Low risk No study protocol data but all reported outcomes are accounted for
Other bias Low risk The study appears to be free of other biases