Complication Registry for Tonsil Surgery

Tonsillar Surgery Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02049372
• Other study ID #: JR/Helsinki/ORL/I
• Status: Completed
• Phase: N/A
• First received: January 27, 2014
• Last updated: January 31, 2014
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 794
• Est. completion date: December 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tonsillar Surgery Complications

Locations

Country	Name	City	State
Finland	Dept of Otorhinolaryngology - Head and Neck Surgery	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient and operative data		September 2011 - February 2012 (6 months)	No
Primary	Complication	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.	September 2011 - February 2012 (6 months)	Yes
Secondary	Hospital stay		September 2011 - February 2012 (6 months)	No