NCT02049372

Complication Registry for Tonsil Surgery

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 794 (actual)
• Sponsor: University of Helsinki · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

Our aim was to establish a feasible method to prospectively register all tonsil surgery-related complications and to find their possible predictive factors. Our long-term objective is to create a surgical complication registration database, which would provide valuable information for quality assurance and give us a benchmarking tool to improve the results of this surgery in our department.

Detailed description

In a six-month period all patients undergoing tonsillectomy or tonsillotomy with or without adenoidectomy were assessed for enrolment. Demographic and clinical data were recorded prospectively in a database which included 57 variables, such as age, gender, co-morbidities, body mass index, American Society of Anesthesiologists Physical Status Classification, indication for surgery, educational level of surgeon (consultant vs. resident), surgical technique, duration of operation and length of hospital stay. After the operation, all patients were given instructions to contact our emergency department (ED) if experiencing any adverse event. Incidents of postoperative complications were recorded during the post-surgical visits to the ED. Only complications warranting a visit to the outpatient department or hospital admission were registered.

Conditions

• Tonsillar Surgery Complications

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-02-01
• Completion: 2013-12-01
• First posted: 2014-01-30
• Last updated: 2014-02-03

Locations

1 site across 1 country: Finland