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

Head and Neck Cancer Clinical Trial

Official title:

A Retrospective Registry of Bleeding, Cardio- and Cerebrovascular Complications in Patients Treated for Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563470
• Other study ID #: HNS01
• Status: Completed
• Phase: N/A
• First received: September 28, 2015
• Last updated: September 29, 2015
• Start date: April 2014
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: National Institute for Health and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Turku	Turku University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		5 years	Yes
Primary	myocardial infarction		5 years	Yes
Primary	stroke		5 years	Yes
Primary	bleeding		30 days	Yes
Primary	decompensated heart failure		5 years	Yes
Primary	new onset atrial fibrillation		5 years	Yes