Complication Registry for Tonsil Surgery

NCT ID: NCT02049372

Last Updated: 2014-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 794 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-12-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Helsinki

OTHER

Sponsor Role: lead

Responsible Party

Leif Back

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leif J Bäck, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dept of Otorhinolaryngology - Head and Neck Surgery

Locations

Dept of Otorhinolaryngology - Head and Neck Surgery

Helsinki, , Finland

Countries

Finland

References

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.

Reference Type: DERIVED

PMID: 25900187 (View on PubMed)

Other Identifiers

JR/Helsinki/ORL/I

Identifier Type: -

Identifier Source: org_study_id