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

Geavlete 2012.

Study characteristics
Methods
  • randomized

  • single center/Romania

Participants Study setting
  • primary and recurrent


Eligibility criteria
  • patients with suspected NMIBC based on positive urinary cytology and ultrasound


Non‐eligibility criteria
  • massive hematuria

  • moderate to severe leukocyturia

  • prior intravesical instillations earlier than ≤ 3 months

  • suspicion of upper urinary tract disease


Intervention cohort
  • participants recruited: 181

  • unifocal/multifocal tumors: 53/89


Comparator cohort
  • participants recruited: 181

  • unifocal/multifocal tumors: NR

Interventions Intervention: WLC + BLC followed by WL‐TURBT + BL‐TURBT
Comparator: WLC followed by WL‐TURBT
Adjuvant instillation therapy: mitomycin C (no further information on dosage)
Outcomes Outcome(s)*
  • recurrence rate

  • detection rate

  • progression rate

  • postoperative treatment modification

  • false‐positive rate


Results
  • median follow‐up: 24 months

  • RFS rate was 31.2% in intervention group vs 45.6% in comparator group

  • recurrence rate at 24 months was 35.4% in intervention group vs 54.0% in comparator group

  • detection rate was 92.2% in intervention group vs 80.3% in comparator group (P = 0.046)

  • progression rate at 24 months was 4.0% in intervention group vs 7.0% in comparator group (P = 0.123)

Funding sources NR
Declarations of interest 1 author: received honoraria from GE Healthcare when spoke at a company‐sponsored symposia
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: "randomized by means of sealed envelopes, thus ensuring allocation concealment by the ‘sequentially‐numbered, opaque, sealed envelopes’ method"
Comment: method of sequence generation clearly described
Allocation concealment (selection bias) Low risk Quote: "randomized by means of sealed envelopes, thus ensuring allocation concealment by the ‘sequentially‐numbered, opaque, sealed envelopes’ method"
Comment: allocation concealment clearly described
Blinding of participants and personnel (performance bias)
Surgeon High risk Quote: "in each case, the urologist performing the procedure was informed on whether HAL‐BLC would be available only after finishing the WLC to ensure maximum attention to the standard investigation"
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: "to ensure the complete objectivity of the evaluation, the urologists performing the follow‐up of WLCs were unaware of the diagnostic and treatment modality initially applied in each case"
Comment: blinding of study personnel reported only at the time point of WLCs
Incomplete outcome data (attrition bias)
Oncological outcomes Unclear risk Quote: "during the follow‐up period, 17 patients in the HAL‐BLC arm and 13 in the WLC arm did not complete the 2 years protocol and were consequently excluded from the trial."
Comment: unclear rate (10% to 20%) of participants 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