Bleeding, Cardio- and Cerebrovascular Complications in Head and Neck Surgery

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT02563470
• Lead Sponsor: University of Turku

Brief Summary

In this retrospective registry trial, the investigators sought to assess the incidence and predictors of cardiovascular and cerebrovascular complications as well as their derivatives (acute coronary syndrome, decompensated heart failure, an episode of atrial fibrillation requiring cardiologist consultation, stroke, pulmonary embolism and venous thromboembolism) in cohort of patients undergoing head and neck surgery.

Detailed Description

Inclusion criteria consisted of all the consecutive patients (n=456) diagnosed with head and neck cancer at Turku University Hospital between 1999 and 2008. Patients receiving palliative procedures were also included. Patients whose treatment had started in other institute or whose treatment was not finished in the investigators institute and patients with primary diagnosis of skin cancer were excluded from this study. All head and neck surgery operations (n=591) were assessed. Information was collected by the first author of this article from referral letters, patient files, anesthesiology reports, intensive care unit reports, laboratory database, radiology database, electrocardiograms and pathology reports. Death was certificated from national authority for collecting and compiling statistics on various fields of society and economy.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-29
• Last Update Submitted: 2015-09-29
• Study First Posted: 2015-09-30
• Last Update Posted: 2015-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 456

Inclusion Criteria

• patients diagnosed with head and neck cancer in Turku University hospital between 1999-2008

Exclusion Criteria

• skin cancer, treatment started in other institute or not finished in our institute

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
all cause mortality	5 years
myocardial infarction	5 years
new onset atrial fibrillation	5 years
bleeding	30 days
stroke	5 years
decompensated heart failure	5 years