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. 2021 Dec 1;2021(12):CD013776. doi: 10.1002/14651858.CD013776.pub2

Neuzillet 2014.

Study characteristics
Methods
  • randomized

  • multicenter (2 centers)/France

Participants Study setting
  • primary


Eligibility criteria
  • patients with primary NMIBC based on cystoscopy and positive urinary cytology


Non‐eligibility criteria
  • suspicion of MIBC, upper urinary tract disease, or massive hematuria


Intervention cohort
  • participants recruited: 72

  • unifocal/multifocal tumors: NR/NR


Comparator cohort
  • participants recruited: 79

  • unifocal/multifocal tumors: NR/NR

Interventions Intervention: WLC + WL‐TURBT followed by BLC + BL‐TURBT
Comparator: WLC followed by WL‐TURBT
Adjuvant instillation therapy: NA
Outcomes Outcome(s)
  • recurrence rate

  • detection rate


Results
  • median follow‐up: 6 weeks

  • Recurrence rate: 20 participants with BLC and 26 participants with WLC

  • Detection rate: average difference on first TURBT for BLC vs WLC was + 0.4 (P = 0.35); in second TURBT + 0.54 (P = 0.19)

Funding sources NA
Declarations of interest NA
Contact of study author Date of contact attempt to first study author: 30 November 2020
Contact status: no reply to date
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "based on a computer‐generated random sequence (1:1), sequentially numbered individual sealed envelopes were prepared by an independent statistician with the group the relevant patient was to be assigned, i.e., a first TURB with WLC and PDD (hexaminolevulinate [HAL]arm) or WLC alone (control arm). Randomization was done the day before the first TURB."
Comment: method of sequence generation clearly described
Allocation concealment (selection bias) Unclear risk Quote: "based on a computer‐generated random sequence (1:1), sequentially numbered individual sealed envelopes were prepared by an independent statistician with the group the relevant patient was to be assigned, i.e., a first TURB with WLC and PDD (hexaminolevulinate [HAL]arm) or WLC alone (control arm). Randomization was done the day before the first TURB"
Comment: allocation concealment unclear
Blinding of participants and personnel (performance bias)
Surgeon High risk Quote: NA
Comment: surgeon unblinded
Blinding of participants and personnel (performance bias)
Participants/study personnel Unclear risk Quote: NA
Comment: unclear whether study participants and other study personnel were blinded
Blinding of outcome assessment (detection bias)
Subjective outcomes (all outcomes) Unclear risk Quote: NA
Comment: unclear whether study personnel were blinded
Incomplete outcome data (attrition bias)
Oncological outcomes Low risk Quote: "excluded from follow‐up n=2 and n=2, respectively (see figure)"
Comment: low rate of participants (< 10%) lost to follow‐up
Selective reporting (reporting bias) Unclear risk Quote: NA
Comment: no protocol available
Other bias Low risk Quote: NA
Comment: no other bias identified