Complication Registry for Tonsil Surgery

Completed

• Conditions: Tonsillar Surgery Complications

• Registration Number: NCT02049372
• Lead Sponsor: University of Helsinki

Brief 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.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-02
• Study Completion: 2013-12
• Status Verified: 2014-01
• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-30
• Last Update Submitted: 2014-01-31
• Last Update Posted: 2014-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 794

Inclusion Criteria

• no age limits
• elective tonsillar surgery

Exclusion Criteria

• procedures carried out due to malignancy
• as a part of multilevel surgery for obstructive sleep apnea
• re-tonsillectomies
• acute operations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complication	September 2011 - February 2012 (6 months)	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.

Secondary Outcome Measures

Name	Time	Method
Hospital stay	September 2011 - February 2012 (6 months)

Trial Locations

Locations (1)

Dept of Otorhinolaryngology - Head and Neck Surgery; 🇫🇮 Helsinki, Finland