Brief Title
Quality of Life After Cardiac Surgery
Official Title
Quality of Life After Cardiac Surgery
Brief Summary
During the last twenty years heart surgery has become safer and the number of patients having heart surgery has increased with more frail patients being offered increasingly complex surgery. Heart operations often improve survival and quality of life (QoL), but that is not true for all patients. Regarding survival, clinicians can measure the risk to life from having a heart operation and the risk to life from not quite precisely, but clinicians have little idea about the impact of heart operations on QoL, which is the outcome that patients care about most. Clinicians are unable to provide patients with robust information on how an operation will affect their QoL. This study will provide this information by analysing the data from patient questionnaires immediately before and after the procedure and monthly thereafter for 12 months.
Detailed Description
The Sponsor shall use existing questionnaires to measure QoL in patients having major heart surgery. QoL will be measured before the operation and monthly afterwards for 12 months in order to answer the following questions: 1. How does having heart surgery affect the QoL immediately after the operation? 2. How long does it take patients to return to the same quality of life they had before the surgery? 3. How long does it take patients to regain any loss of quality of life due to the operation? Does quality of life improve thereafter? 4. What proportion of patients will achieve a net benefit in QoL? 5. Are there features that can predict who will benefit in terms of QoL and who will not? The Sponsor will use the data to develop an electronic calculator to enable quick and robust evaluation of the impact of heart surgery on the QoL of individuals. Patients will then be able to give truly informed consent and to decide if they wish have surgery based on a full knowledge of both surgical risk and the potential impact on QoL.
Study Type
Observational
Primary Outcome
Change in Quality of Life using Questionnaire EQ-5D
Secondary Outcome
Change in Quality of Life using Questionnaire SF-12
Condition
Aortic Valve Stenosis
Intervention
Cardiac Surgery
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
8004
Start Date
July 19, 2019
Completion Date
May 13, 2022
Primary Completion Date
May 13, 2021
Eligibility Criteria
Inclusion Criteria: - EuroSCORE II ≥ 3% or EuroSCORE logistic of ≥ 6% - Patients undergoing routine/ urgent cardiac surgery - Patients must have the ability to provide informed consent Exclusion Criteria: - Patients undergoing salvage or emergency operations
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Samer Nashef, 01223 639710, [email protected]
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT04231461
Organization ID
P02500
Responsible Party
Sponsor
Study Sponsor
Papworth Hospital NHS Foundation Trust
Study Sponsor
Samer Nashef, Study Director, Chief Investigator Royal Papworth Hospital
Verification Date
January 2020