Longo 2013.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: parallel group |
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Participants |
Inclusion criteria: people who underwent a TURBT for suspicious
bladder cancer diagnosed by WLC Exclusion criteria: not reported Number randomized: 66 participants to undergo WLC TURBT alone and 71 participants to undergo NBI + WLC TURBT Number analyzed by authors: 66 participants who underwent WLC TURBT alone and 71 participants who underwent NBI + WLC TURBT Baseline characteristics of participants analyzed Comparator group, n = 66
Intervention group, n = 71
Subsequent intravesical treatment among either group: no documentation of subsequent intravesical treatment |
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Interventions |
Comparator arm: WLC TURBT alone Intervention arm: NBI + WLC TURBT (Olympus) |
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Outcomes | Surgical complication (Clavien‐Dindo) Mean time to catheter removal Absence of muscle tissue in the specimen False‐positive rate |
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Funding sources | Not reported | |
Declarations of interest | Not reported | |
Notes |
Contact with study author Date of contact attempt: 5 October 2020 Contact status: no reply to‐date |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: Authors did not specify how random assignments were generated; however, only the abstract was available. |
Allocation concealment (selection bias) | Unclear risk | Comment: The authors did not describe how, if any, concealment of allocations prior to assignment was conducted; however, only the abstract was available. |
Blinding of participants and personnel (performance bias) | High risk | Comment: Personnel could not be blinded due to the nature of the intervention. |
Blinding of outcome assessment (detection bias) Subjective outcomes: time to disease recurrence, minor adverse event | High risk | Comment: Authors did not specify how, if any, outcome assessment blinding was achieved. The detection of minor adverse events would be affected by a lack of blinding of outcome assessors. |
Blinding of outcome assessment (detection bias) Objective outcomes: major adverse event | Low risk | Comment: The authors did not specify how, if any, blinding of outcome assessment was conducted. However, we do not expect the lack of blinding to bias the detection or reporting of major adverse events as no clinical judgement was involved. |
Incomplete outcome data (attrition bias) Major adverse event | Low risk | Comment: Of the 137 participants randomized, 66 and 71 were randomized to the WLC TURBT arm and to the NBI + WLC TURBT arm, respectively. All participants were included in the analysis of adverse events. The attrition rate was less than 10% in both arms. |
Incomplete outcome data (attrition bias) Minor adverse event | Low risk | Comment: Of the 137 participants randomized, 66 and 71 were randomized to the WLC TURBT arm and to the NBI + WLC TURBT arm, respectively. All participants were included in the analysis of adverse events. The attrition rate was less than 10% in both arms. |
Selective reporting (reporting bias) | Unclear risk | Comment: No associated trial registration was found. |
Other bias | Low risk | Comment: No additional potential sources of bias were identified. |