AIM OF THE STUDY: To study the effects, secondary effects and security of the intrasurgical application of mitomicyn C during endonasal and endocanalicular dacryocystorhinostomy with diode laser (TLA-ELA DCR). METHODS: We carried out a randomized, prospective, interventional and double blind study in 200 patients: intrasurgical mitomicyn C was applied in 150 of then (0.4 mgr/0.2 ml) for 5 minutes by means of a polivinil acetate dressing over the osteotomy. In other 50 patients MMC was not used we followed up at 24 hours, 10 days and 1, 3 and 6 months after surgery. Endoscopic aspects and possible complications were valued. The results were compared using the Chi-squared test with the Yates correction. We looked for the presence or abscense of secondary effects in the application of mitomicyn C. RESULTS: The average follow up was 15.25 months (range 6 to 21 months). The percentages of alterations for excesive scarring were 21.77% in patients without and MAC 8.03% in the ones MMC. The difference was statisticaly significant (p = 0.02). We did not find secondary effects due to application of mitomcyn. CONCLUSIONS: Intrasurgical application of topical MMC during TLA-ENL DCR reduces the number of pathological findings due to scarring of the surrouding area of the new drainage without secondary effects.
RCT Entities:
AIM OF THE STUDY: To study the effects, secondary effects and security of the intrasurgical application of mitomicyn C during endonasal and endocanalicular dacryocystorhinostomy with diode laser (TLA-ELA DCR). METHODS: We carried out a randomized, prospective, interventional and double blind study in 200 patients: intrasurgical mitomicyn C was applied in 150 of then (0.4 mgr/0.2 ml) for 5 minutes by means of a polivinil acetate dressing over the osteotomy. In other 50 patientsMMC was not used we followed up at 24 hours, 10 days and 1, 3 and 6 months after surgery. Endoscopic aspects and possible complications were valued. The results were compared using the Chi-squared test with the Yates correction. We looked for the presence or abscense of secondary effects in the application of mitomicyn C. RESULTS: The average follow up was 15.25 months (range 6 to 21 months). The percentages of alterations for excesive scarring were 21.77% in patients without and MAC 8.03% in the ones MMC. The difference was statisticaly significant (p = 0.02). We did not find secondary effects due to application of mitomcyn. CONCLUSIONS: Intrasurgical application of topical MMC during TLA-ENL DCR reduces the number of pathological findings due to scarring of the surrouding area of the new drainage without secondary effects.