Complication Registry for Tonsil Surgery
Developing a Prospective Registry for Complications in Otorhinolaryngologic Surgery: Tonsil Surgery as a Pilot Cohort
1 other identifier
observational
794
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 27, 2014
CompletedFirst Posted
Study publicly available on registry
January 30, 2014
CompletedFebruary 3, 2014
January 1, 2014
5 months
January 27, 2014
January 31, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (1)
Hospital stay
September 2011 - February 2012 (6 months)
Other Outcomes (1)
Patient and operative data
September 2011 - February 2012 (6 months)
Eligibility Criteria
From September 2011 to February 2012, all patients undergoing tonsillectomy or tonsillotomy with or without adenoidectomy were assessed for enrolment.
You may qualify if:
- no age limits
- elective tonsillar surgery
You may not qualify if:
- procedures carried out due to malignancy
- as a part of multilevel surgery for obstructive sleep apnea
- re-tonsillectomies
- acute operations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept of Otorhinolaryngology - Head and Neck Surgery
Helsinki, 00029, Finland
Related Publications (1)
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.
PMID: 25900187DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Leif J Bäck, MD PhD
Dept of Otorhinolaryngology - Head and Neck Surgery
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
January 27, 2014
First Posted
January 30, 2014
Study Start
September 1, 2011
Primary Completion
February 1, 2012
Study Completion
December 1, 2013
Last Updated
February 3, 2014
Record last verified: 2014-01