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

Kriegmaier 2002.

Study characteristics
Methods
  • randomized, phase III

  • multicenter (8 centers)/Austria, Germany

Participants Study setting
  • primary and recurrent


Eligibility criteria
  • patients suspicious for primary BCa or tumor recurrence


Non‐eligibility criteria
  • NR


Intervention cohort
  • participants recruited: 83

  • unifocal/multifocal tumors: NR


Comparator cohort
  • participants recruited: n = 82

  • unifocal/multifocal tumors: NR

Interventions Intervention: PDD‐TURBT
Comparator: WL‐TURBT
Adjuvant instillation therapy: NA
Outcomes Outcome(s)
  • residual tumor

  • detection rate


Results
  • median follow‐up: 2 weeks

  • RFS rate was 67.3% in intervention group vs 46.9% in comparator group (P < 0.031)

Funding sources NR
Declarations of interest NR
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) Unclear risk Quote: "the randomization procedure was stratified according to participating centers and further by the potentially prognostically relevant risk score, defined according to the results of European Organization for the Research and Treatment of Cancer studies 30831, 30790 and 30782 as 1—recurrence, 2—early recurrence at less than 12 months, 3—bacillus Calmette‐Guerin therapy less than 12 months in duration and 4—a history of carcinoma in situ"
Comment: method of sequence generation unclear
Allocation concealment (selection bias) Unclear risk Quote: "the randomization procedure was stratified according to participating centers and further by the potentially prognostically relevant risk score, defined according to the results of European Organization for the Research and Treatment of Cancer studies 30831, 30790 and 30782 as 1—recurrence, 2—early recurrence at less than 12 months, 3—bacillus Calmette‐Guerin therapy less than 12 months in duration and 4—a history of carcinoma in situ"
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 High risk Quote: NA
Comment: loss to follow‐up was > 20%
Selective reporting (reporting bias) Unclear risk Quote: NA
Comment: no protocol available
Other bias Low risk Quote: NA
Comment: no other bias identified