A randomized controlled trial of adjuvant mitomycin‐c in endoscopic surgery for laryngotracheal stenosis
| Autor: | Mark S. Courey, Joseph Chang, Katherine C. Yung |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Administration Topical Mitomycin Subglottic stenosis Placebo law.invention 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law medicine Adjuvant therapy Humans Prospective Studies 030223 otorhinolaryngology Peak flow meter Aged measurement_unit Laryngoscopy business.industry Laryngostenosis Middle Aged medicine.disease Surgery Clinical trial Stenosis Treatment Outcome Otorhinolaryngology Chemotherapy Adjuvant 030220 oncology & carcinogenesis measurement_unit.measuring_instrument Female Tracheal Stenosis business Laryngotracheal stenosis |
| Zdroj: | The Laryngoscope. 130:706-711 |
| ISSN: | 1531-4995 0023-852X |
| DOI: | 10.1002/lary.28025 |
| Popis: | Objectives/hypothesis Topical mitomycin-C (MMC) application is a commonly accepted adjuvant therapy in the surgical treatment for laryngotracheal stenosis (LTS). However, the efficacy of MMC has not been examined in a prospective, randomized clinical trial in humans. We aimed to examine the efficacy of MMC in the treatment of LTS patients as compared to a placebo-controlled group. Study design Prospective, randomized, double-blind, placebo-controlled clinical trial. Methods Fifteen patients with LTS were enrolled in a 24-month trial and randomized into one of two groups: 1) endoscopic surgical treatment with topical application of MMC or 2) endoscopic surgical treatment with topical application of saline. Postoperatively, patients were evaluated at standardized intervals with a symptom questionnaire and spirometry. Subsequent surgery was performed as needed based on relapse of stenosis on exam and patient-reported symptom severity. Results The average interval between surgical treatments was 17.9 months in the placebo group and 17.4 months in the MMC group (P = .95). There was no difference in magnitude of peak inspiratory flow (PIF) improvement between groups. The average magnitude of PIF change was 1.3 L/sec and 1.1 L/sec for the placebo and MMC groups, respectively (P = .64). Similarly, there was no difference in magnitude of symptom improvement or duration of symptom improvement between the two groups. Conclusions This prospective, randomized. double-blind. placebo-controlled trial suggests that the use of MMC as a topical adjuvant therapy has no additional benefit in the endoscopic surgical management of LTS. Further study is needed. Level of evidence 1b Laryngoscope, 130:706-711, 2020. |
| Databáze: | OpenAIRE |
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