Developing a Registry for Complications in Otorhinolaryngologic Surgery: Tonsil Surgery as a Pilot Cohort.

ABSTRACT

OBJECTIVE: To find a suitable method to prospectively register all tonsil surgery-related complications. STUDY DESIGN: Prospective cohort study. SETTING: Tertiary care center. SUBJECTS AND METHODS: From September 2011 to February 2012, patients undergoing tonsillectomy or tonsillotomy were enrolled. A wide range of demographic and clinical data including incidents of postoperative complications was recorded prospectively, and patient records were reviewed 9 months after the end of study period. We evaluated the coverage of prospective data recording, analyzed the complication rates, and assessed the process of registration. RESULTS: A total of 573 patients were recruited. The study registry including 57 variables required the completion of missing data before analysis. Of all 79 patients with a complication, 69.6% were captured prospectively at the emergency department, and the rest were found when reviewing the patient records. The proportion of prospectively captured complications was highest for the most common complications (eg, 81.1% for secondary hemorrhage). The overall complication rate was 13.8%. Secondary hemorrhage was the most common complication, with the incidence of 9.6%. CONCLUSION: We have demonstrated the initial feasibility of a prospective complication registry for otorhinolaryngology procedures, and the results can be applied accordingly. We also present 5 practical recommendations when initiating a functional registry. Particular attention should be paid to recognition and registration of both rare and serious events. Regular analysis of the results is required in order to respond to possible changes in the incidence or nature of complications.