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OpenTrials
Completed

NCT Number: NCT02049372

Complication Registry for Tonsil Surgery

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.

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Key information

Conditions

Tonsillar Surgery Complications

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept of Otorhinolaryngology - Head and Neck Surgery

Helsinki, 00029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Complication

    Time frame: 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 outcomes

  1. Hospital stay

    Time frame: September 2011 - February 2012 (6 months)

Other outcomes

  1. Patient and operative data

    Time frame: September 2011 - February 2012 (6 months)

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jan 30, 2014
Registry last updated
Feb 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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