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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Royal Papworth Hospital
Cambridge, Cambridgeshire, United Kingdom
Start Date
July 19, 2019
Primary Completion Date
April 30, 2024
Completion Date
May 21, 2024
Last Updated
December 3, 2024
2,925
ACTUAL participants
Cardiac Surgery
PROCEDURE
Lead Sponsor
Papworth Hospital NHS Foundation Trust
NCT07477002
NCT05672836
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06137807