Complication Registry for Tonsil Surgery

January 31, 2014 updated by: Leif Back, University of Helsinki

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

794

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Dept of Otorhinolaryngology - Head and Neck Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
September 2011 - February 2012 (6 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital stay
Time Frame: September 2011 - February 2012 (6 months)
September 2011 - February 2012 (6 months)

Other Outcome Measures

Outcome Measure
Time Frame
Patient and operative data
Time Frame: September 2011 - February 2012 (6 months)
September 2011 - February 2012 (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Investigators

  • Principal Investigator: Leif J Bäck, MD PhD, Dept of Otorhinolaryngology - Head and Neck Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (ESTIMATE)

January 30, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2014

Last Update Submitted That Met QC Criteria

January 31, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JR/Helsinki/ORL/I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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