Clinical trial NCT02049372: Complication Registry for Tonsil Surgery
Official title: Developing a Prospective Registry for Complications in Otorhinolaryngologic Surgery: Tonsil Surgery as a Pilot Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tonsillar Surgery Complications
Keywords: complications
tonsillectomy
tonsillotomy
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 794
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From September 2011 to February 2012, all patients undergoing tonsillectomy or tonsillotomy with or without adenoidectomy were assessed for enrolment.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complication
timeFrame: September 2011 - February 2012 (6 months)
Secondary outcomes:
measure: Hospital stay
timeFrame: September 2011 - February 2012 (6 months)
Other outcomes:
measure: Patient and operative data
timeFrame: September 2011 - February 2012 (6 months)
Locations:
city: Helsinki
country: Finland
facility: Dept of Otorhinolaryngology - Head and Neck Surgery
Study officials:
affiliation: Dept of Otorhinolaryngology - Head and Neck Surgery
name: Leif J Bäck, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruohoalho J, Makitie AA, Atula T, Takala A, Keski-Santti H, Aro K, Haapaniemi A, Markkanen-Leppanen M, Back LJ. Developing a Registry for Complications in Otorhinolaryngologic Surgery: Tonsil Surgery as a Pilot Cohort. Otolaryngol Head Neck Surg. 2015 Jul;153(1):34-40. doi: 10.1177/0194599815582156. Epub 2015 Apr 21.