Quality of Life After Cardiac Surgery

NCT04231461 | Completed

• 1 other identifier: P02500
• Study Type: observational
• Target: 2,925
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life using Questionnaire EQ-5D

  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.

  12 Months

Secondary Outcomes (1)

• Change in Quality of Life using Questionnaire SF-12

  12 Months

Other Outcomes (2)

• Change in Quality of Life using Questionnaire LOT

  12 months

• Change in Quality of Life using Questionnaire PANAS

  12 months

Interventions

Cardiac Surgery PROCEDURE

Routine or urgent cardiac surgery

Also known as: Aortic Valve Procedure, Mitral Valve Procedure, Tricuspid Valve Procedure, Procedure on Aorta, Other major cardiac intervention, Other minimal access incisions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adults able to understand the patient information sheet written in English.

You may qualify if:

• EuroSCORE II ≥ 3% or EuroSCORE logistic of ≥ 6%
• Patients undergoing routine/ urgent cardiac surgery
• Patients must have the ability to provide informed consent

You may not qualify if:

• Patients undergoing salvage or emergency operations

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead

Study Sites (1)

Royal Papworth Hospital

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Diseases

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Samer Nashef

  Chief Investigator Royal Papworth Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: January 18, 2020
• Study Start: July 19, 2019
• Primary Completion: April 30, 2024
• Study Completion: May 21, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)