Complication Registry for Tonsil Surgery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02049372

Enrollment

794

Registered

2014-01-30

Start date

2011-09-30

Completion date

2013-12-31

Last updated

2014-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tonsillar Surgery Complications

Keywords

complications, tonsillectomy, tonsillotomy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Hospital stay	September 2011 - February 2012 (6 months)

Other

Measure	Time frame
Patient and operative data	September 2011 - February 2012 (6 months)

Countries

Finland

Outcome results