PURPOSE: To assess the effect of mitomycin C on surgical success rate of dacryocystorhinostomy and silicone intubation in patients with improper flaps. METHODS: The study was a randomized clinical trial. The patients with indication for dacryocystorhinostomy surgery with silicone intubation (inappropriate lacrimal sac or nasal mucosal flaps during surgery and/or history of dacryocystitis in the past 3 months) were randomly assigned to application of mitomycin C (0.02%) on surgical flaps (group A) or a control group without mitomycin C application (group B). Main outcome measures were subjective symptomatic improvement and result of irrigation test at last follow-up visit. RESULTS: The study enrolled 88 patients (88 eyes); there were 42 patients in group A and 46 patients in group B. There was an average follow-up of 10 months (range 6-15 months) following surgery. Significant improvement (no tearing with patent lacrimal system in irrigation) was observed in 31 patients (73.8%) in group A and 32 patients (69.6%) in group B. There was no statistically significant difference in no improvement (no change in tearing state and obstruction in irrigation test), relative improvement (decreased tearing and passage of fluid with force in irrigation test), and significant improvement rate between the 2 groups of study (p>0.05). CONCLUSIONS: Application of mitomycin C on surgical flaps during dacryocystorhinostomy surgery with silicone intubation in patients with improper flaps has no proven beneficial effect on success rate of surgery.
RCT Entities:
PURPOSE: To assess the effect of mitomycin C on surgical success rate of dacryocystorhinostomy and silicone intubation in patients with improper flaps. METHODS: The study was a randomized clinical trial. The patients with indication for dacryocystorhinostomy surgery with silicone intubation (inappropriate lacrimal sac or nasal mucosal flaps during surgery and/or history of dacryocystitis in the past 3 months) were randomly assigned to application of mitomycin C (0.02%) on surgical flaps (group A) or a control group without mitomycin C application (group B). Main outcome measures were subjective symptomatic improvement and result of irrigation test at last follow-up visit. RESULTS: The study enrolled 88 patients (88 eyes); there were 42 patients in group A and 46 patients in group B. There was an average follow-up of 10 months (range 6-15 months) following surgery. Significant improvement (no tearing with patent lacrimal system in irrigation) was observed in 31 patients (73.8%) in group A and 32 patients (69.6%) in group B. There was no statistically significant difference in no improvement (no change in tearing state and obstruction in irrigation test), relative improvement (decreased tearing and passage of fluid with force in irrigation test), and significant improvement rate between the 2 groups of study (p>0.05). CONCLUSIONS: Application of mitomycin C on surgical flaps during dacryocystorhinostomy surgery with silicone intubation in patients with improper flaps has no proven beneficial effect on success rate of surgery.
Authors: E Emanuelli; F Pagella; G Dané; A Pusateri; G Giourgos; P Carena; E Antoniazzi; P Verdecchia; E Matti Journal: Acta Otorhinolaryngol Ital Date: 2013-10 Impact factor: 2.124