Thomas Prasannaraj1, B Y Praveen Kumar, Indira Narasimhan, K V Shivaprakash. 1. Department of Otorhinolaryngology, R.L. Jalappa Hospital and Research Centre, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education, Tamaka, Kolar, India. drtpr@yahoo.com
Abstract
PURPOSE: The purpose of this study is to observe the effect of intraoperative topical application of mitomycin C (MMC) on the results of endoscopic dacryocystorhinostomy. DESIGN: This is a prospective, randomized, controlled, single-blind study. SETTINGS: Hospitalized treatment was done in a tertiary medical college hospital and research center that deals with a predominantly rural population. PATIENTS: Patients with primary acquired postsaccal obstruction causing chronic dacryocystitis were considered. METHODS: A total of 38 patients were randomized into either a mitomycin group or a control group. Both of these groups were subjected to an identical surgical procedure, except that 0.2 mg/dL of MMC was used in the mitomycin group, whereas normal saline was used in the control group. The follow-up period was at least 6 months. An asymptomatic patient with a visible stoma at nasendoscopy and free flow of saline into the nose with lacrimal syringing after 6 months after surgery was used as criteria for defining a successful result. RESULTS: The success rate was 82.3% when MMC was used and 85.7% among the controls (P > .05). Granulations, adhesions, and obliterative sclerosis occurred in a similar number of patients of both groups. However, granulations and adhesions did not have a bearing on the success rate in either group. CONCLUSION:Mitomycin C did not appear to influence the occurrence of granulations, synechiae, or obliterative sclerosis, nor did it alter the success rate significantly.
RCT Entities:
PURPOSE: The purpose of this study is to observe the effect of intraoperative topical application of mitomycin C (MMC) on the results of endoscopic dacryocystorhinostomy. DESIGN: This is a prospective, randomized, controlled, single-blind study. SETTINGS: Hospitalized treatment was done in a tertiary medical college hospital and research center that deals with a predominantly rural population. PATIENTS: Patients with primary acquired postsaccal obstruction causing chronic dacryocystitis were considered. METHODS: A total of 38 patients were randomized into either a mitomycin group or a control group. Both of these groups were subjected to an identical surgical procedure, except that 0.2 mg/dL of MMC was used in the mitomycin group, whereas normal saline was used in the control group. The follow-up period was at least 6 months. An asymptomatic patient with a visible stoma at nasendoscopy and free flow of saline into the nose with lacrimal syringing after 6 months after surgery was used as criteria for defining a successful result. RESULTS: The success rate was 82.3% when MMC was used and 85.7% among the controls (P > .05). Granulations, adhesions, and obliterative sclerosis occurred in a similar number of patients of both groups. However, granulations and adhesions did not have a bearing on the success rate in either group. CONCLUSION:Mitomycin C did not appear to influence the occurrence of granulations, synechiae, or obliterative sclerosis, nor did it alter the success rate significantly.
Authors: G Savino; R Battendieri; S Traina; G Corbo; G D'Amico; M Gari; E Scarano; G Paludetti Journal: Acta Otorhinolaryngol Ital Date: 2014-02 Impact factor: 2.124