Costa 2007.
Methods |
Study design: randomized controlled trial, parallel group Unit of analysis: participants Number randomized: 50 in total, 13 in Group SS (saline solution), 17 in Group 5‐FU1 (5‐fluorouracil), 9 in Group 5‐FU3, 11 in Group C Number of arms: 4 Enrollment start year: not reported Length of follow‐up: 60 days Sample size calculations: not reported Losses to follow‐up: none |
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Participants |
Country: Brazil Age (mean (SD)): not reported Females (n (%)): not reported Inclusion criteria: patients with dacryocystitis Exclusion criteria: patients with nasal affections such as septal deviation, turbinate hypertrophy, nasal fractures, and other lacrimal system problems Study group differences: not reported |
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Interventions |
Intervention 1: Group 5‐FU1: DCR and a 0.50 mL injection of 5‐FU (1 mL of 5‐FU (250 mg/10 mL) added to 4 mL of 0.9% saline solution) during surgery Intervention 2: Group 5‐FU3: DCR and three 4 mL injections of 5‐FU (1 during surgery, 1 on the third postoperative day, and 1 on the fifth postoperative day) with the same concentration as that of Group 5‐FU1, for a total dose of 15 mg Intervention 3: Group SS: DCR and an injection of saline solution (4 mL of 0.9% saline) during the surgery, and 0.5 mL of the saline solution injected into the nasal mucosa at the end of the surgery Comparison intervention: Group C: DCR only |
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Outcomes |
Measured outcomes:
Adverse events: total ostium occlusion by the healing tissue, persistent epiphora |
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Identification |
Author name: Marilisa Nano Costa Institution: State University of Campinas Email: m.nano@uol.com.br |
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Notes |
Funding source: not reported Declarations of interest: not reported Trial registration number: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of random sequence generation was not specified. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment mechanism was not specified. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Masking of participants was not specified. Study personnel would not have been blinded due to the differences in the surgical interventions. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Masking of outcome assessors was not specified. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data; all participants who had been randomized were analyzed. |
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'. |