Skip to main content
. 2020 Apr 7;2020(4):CD012309. doi: 10.1002/14651858.CD012309.pub2

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
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
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
Outcomes Measured outcomes:
  • functional success, defined as the relief of epiphora

  • anatomic success, defined as patency to lacrimal irrigation

  • ostium size on nasal endoscopy postoperatively


Adverse events: total ostium occlusion by the healing tissue, persistent epiphora
Identification Author name: Marilisa Nano Costa
Institution: State University of Campinas
Email: m.nano@uol.com.br
Notes Funding source: not reported
Declarations of interest: not reported
Trial registration number: not reported
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'.