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

Babjuk 2005.

Study characteristics
Methods
  • randomized, parallel unblinded

  • single center/Czech Republic

Participants Study setting
  • primary and recurrent

  • only Ta/T1


Eligibility criteria
  • patients with suspected primary or recurrent superficial BCa planned for TURBT


Non‐eligibility criteria
  • surgical or instillation therapy within 3 months


Intervention cohort
  • participants recruited: 64

  • unifocal/multifocal tumors: 15/45


Comparator cohort
  • participants recruited: 64

  • unifocal/multifocal tumors: 24/38

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

  • recurrence rate

  • progression rate (to muscle invasive disease)


Results
  • median follow‐up: 24 months

  • RFS was 17.1 months in intervention group vs 8.1 months in comparator group

  • RFS rate was 40% in intervention group vs 28% in comparator group

Funding sources Grant of Czech Health Ministry
Declarations of interest NA
Contact of study author Date of contact attempt to first study author: 30 November 2020
Contact status: reply by author; original study data no longer available
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The patients were randomly assigned to two groups."
Comment: method of sequence generation unclear
Allocation concealment (selection bias) Unclear risk Quote: "The patients were randomly assigned to two groups."
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: "six [participants] (two in group A and four in group B) were excluded after histological examination, as in two there was no histological evidence of TCC, in three there was muscle invasion, and in one there was a multiple T1G3 tumour with concomitant carcinoma in situ (CIS) treated with immediate cystectomy."
Comment: loss to follow‐up was < 10%, and variation in loss to follow‐up between groups was low
Selective reporting (reporting bias) Unclear risk Quote: NA
Comment: no protocol available
Other bias Low risk Quote: NA
Comment: no other bias identified