Quality of Life After Cardiac Surgery

Completed

• Conditions: Mitral Valve Disease; Tricuspid Valve Disease; Aorta Disease; Coronary Artery Bypass Graft; Aortic Valve Stenosis

• Registration Number: NCT04231461
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

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 Timeline

• Study Start: 2019-07-19
• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-18
• Primary Completion: 2024-04-30
• Study Completion: 2024-05-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2925

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life using Questionnaire EQ-5D	12 Months	Conduct questionnaire EQ-5D to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life using Questionnaire SF-12	12 Months	Conduct questionnaire SF-12 to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure.

Trial Locations

Locations (1)

Royal Papworth Hospital; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom