Penttilä 2011.
Methods |
Study design: randomized controlled trial, parallel group Unit of analysis: eyes Number randomized: 30 in total, 15 per group Number of arms: 2 Enrollment start year: 2004 Length of follow‐up: 6 months Sample size calculations: not reported Losses to follow‐up: 2 (6.25%) lost to follow‐up (reasons and groups not reported) |
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Participants |
Country: Finland Age (mean (SD)): 65 (11) in the MMC group, 70 (10) in the EN‐DCR only group Females (n (%)): 27 (90) in total, 13 (86.7) in the MMC group, 14 (93.3) in the EN‐DCR only group Inclusion criteria: aged 18 years, American Society of Anesthesiologist physical status was I‐III, scheduled for revision lacrimal pathway surgery due to tearing or recurrent infection after failed EX‐DCR or EN‐DCR Exclusion criteria: presaccal obstruction; malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway; mental disability; pregnancy; breastfeeding Study group differences: not significant |
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Interventions |
Intervention: EN‐DCR with application of 0.4 mg/mL MMC Comparison intervention: EN‐DCR alone |
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Outcomes |
Measured outcomes:
Adverse events: additional surgery for abnormalities |
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Identification |
Author name: Elina Penttila Institution: Department of Otorhinolaryngology at Kuopio University Hospital Email: grigori.smirnov@kuh.fi |
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Notes |
Funding source: not reported Declarations of interest: none Trial registration number: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The allocation was computer‐generated and a sealed opaque envelope method was used to ensure blinding." |
Allocation concealment (selection bias) | Low risk | "The allocation was computer‐generated and a sealed opaque envelope method was used to ensure blinding." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Masking of participants and personnel was not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Masking of outcome assessors was not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis was not followed: 2/32 (6.25%) participants were withdrawn and not included in the final analysis, however we determined that this was unlikely to have impacted on the results. |
Selective reporting (reporting bias) | Unclear risk | No trial or protocol registration available for comparison to ascertain selective outcome reporting. |
Other bias | Unclear risk | There was insufficient information to permit a judgement of 'low risk' or 'high risk'. |