- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02049372
Complication Registry for Tonsil Surgery
Developing a Prospective Registry for Complications in Otorhinolaryngologic Surgery: Tonsil Surgery as a Pilot Cohort
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Helsinki, Finland, 00029
- Dept of Otorhinolaryngology - Head and Neck Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Leif J Bäck, MD PhD, Dept of Otorhinolaryngology - Head and Neck Surgery
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
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.
Clinical Trials on Tonsillar Surgery Complications
-
Olubukola NafiuNot yet recruitingSurgery | Tonsillar Hypertrophy | Adenoid Hypertrophy
-
Centre Hospitalier Universitaire de BesanconRecruitingTonsillar DisorderFrance
-
Duke UniversityWithdrawnSurgical Complications From Surgery | Surgical Complications From Bladder Surgery | Surgical Complications From Bowel Surgery
-
Imam Abdulrahman Bin Faisal UniversityCompletedPostoperative Pain | Inflammatory Response | Tonsillectomy | Peri-tonsillar Analgesic InfiltrationSaudi Arabia
-
Poudre Valley Health SystemTerminatedSurgery | Surgery--ComplicationsUnited States
-
University of KwaZuluMedical Research Council, South AfricaCompletedMortality | Surgery | Surgery- ComplicationsSouth Africa, Algeria, Benin, Burundi, Cameroon, Congo, The Democratic Republic of the, Congo, Egypt, Ethiopia, Gambia, Ghana, Kenya, Libyan Arab Jamahiriya, Madagascar, Mali, Mauritius, Namibia, Nigeria, Niger, Senegal, Tanzania, Tog... and more
-
Seoul National University HospitalSamsung Medical Center; Chung-Ang University Hosptial, Chung-Ang University... and other collaboratorsCompletedTonsillar HypertrophyKorea, Republic of
-
Baylor Research InstituteChiesi USA, Inc.RecruitingSurgery | Cardiac Surgery | Surgery--Complications | Percutaneous Coronary InterventionUnited States
-
Western University, CanadaNot yet recruitingSurgery | Surgery--Complications | Pulmonary Complication
-
Faiza GabaQueen Mary University of London; University of Hertfordshire; University of Aberdeen and other collaboratorsRecruitingGynecologic Cancer | Surgery | Surgery--ComplicationsUnited Kingdom