Tonsillar Surgery ComplicationsNCT02049372
Complication Registry for Tonsil Surgery
An observational study of Tonsillar Surgery Complications, run by University of Helsinki at 1 site in Finland.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tonsillar Surgery Complications
- How many people
- 794 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2011to Dec 2013
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: From September 2011 to February 2012, all patients undergoing tonsillectomy or tonsillotomy with or without adenoidectomy were assessed for enrolment.
Who may be able to join
- no age limits
- elective tonsillar surgery
Who cannot join
- procedures carried out due to malignancy
- as a part of multilevel surgery for obstructive sleep apnea
- re-tonsillectomies
- acute operations
Trial locations and contacts
1 site in 1 country.
Finland1 site
Dept of Otorhinolaryngology - Head and Neck Surgery
Helsinki, 00029
About this study
Official title: 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.
Read the 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.
- Conditions
- Tonsillar Surgery Complications
- Keywords
- complications, tonsillectomy, tonsillotomy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: September 2011 - February 2012 (6 months)
Secondary outcomes (1)
Hospital stay
Measured: September 2011 - February 2012 (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startSep 2011
- Primary completionFeb 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tonsillar Surgery ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 794 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leif Back, University of Helsinki
- Investigators
- Leif J Bäck, MD PhD, Principal investigator, Dept of Otorhinolaryngology - Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049372
- Sponsor's protocol ID
- JR/Helsinki/ORL/I
- Status last verified
- Jan 2014
- First submitted
- 27 Jan 2014
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25900187
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Prospective Registry for Complications in Otorhinolaryngologic Surgery: Tonsil Surgery as a Pilot Cohort
- ClinicalTrials.gov ID
- NCT02049372
- Acronym / sponsor ID
- JR/Helsinki/ORL/I
- Conditions
- Tonsillar Surgery Complications
- Keywords
- complications, tonsillectomy, tonsillotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 794 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From September 2011 to February 2012, all patients undergoing tonsillectomy or tonsillotomy with or without adenoidectomy were assessed for enrolment.
Key inclusion criteria (2 listed)
- no age limits
- elective tonsillar surgery
Key exclusion criteria (4 listed)
- procedures carried out due to malignancy
- as a part of multilevel surgery for obstructive sleep apnea
- re-tonsillectomies
- acute operations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Hospital stay
Time frame: September 2011 - February 2012 (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
- Derived from this study: PubMed 25900187Ruohoalho 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leif J Bäck, MD PhD principal investigator
Dept of Otorhinolaryngology - Head and Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tonsillar Surgery Complications, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication (time frame: September 2011 - February 2012 (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02049372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2014.