Postoperative; Dysfunction Following Cardiac Surgery Clinical Trial
— FORCAST6Official title:
The First Planned Outpatient Review After Cardiac Surgery: Is Six Weeks Too Long?
NCT number | NCT02832427 |
Other study ID # | 203366 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | May 2017 |
Verified date | July 2019 |
Source | Hull and East Yorkshire Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Although the first outpatient review following cardiac surgery is conventionally scheduled
for six weeks after hospital discharge, there is no evidence to support this practice.
Thirty-day mortality and morbidity rates, which are now widely used as indicators of the
quality of surgical care, reveal rates that are higher than corresponding in-hospital rates.
Secondly, the rates for mortality and morbidity occurring up to 6 weeks after surgery are not
known. The objectives of our study are to determine the postoperative mortality and morbidity
rates in the 6-week interval between hospital discharge and the first planned specialist
review after cardiac surgery, and to assess the level of patient satisfaction with current
practice.
The study will enrol eligible patients who are undergoing elective and urgent coronary artery
bypass and/or valve surgery at our institution over a 6-month period and provide them with
study information. Prior to discharge after surgery, prospective participants will be
consented and given a questionnaire to take home, complete and bring along to the outpatient
appointment.
The investigators will analyse the data to determine the rates and timing of the
complications, and the impact on postoperative recovery. The investigators will also assess
the level of patient satisfaction with the current practice.
Appropriate conclusions either in support of current practice or, a change in practice would
be drawn..
Status | Completed |
Enrollment | 85 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Adult patients undergoing coronary artery bypass and/or valve surgery. - Patients who can read and write in English Exclusion Criteria: - Postoperative stroke with neurologic deficit |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Castle Hill Hospital | Kingston-Upon-Hull | East Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Hull and East Yorkshire Hospitals NHS Trust |
United Kingdom,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of participants with postoperative mortality, or complications who require further interventions and hospital readmission . | Patients who require further interventions and hospital readmission. | 6 weeks | |
Secondary | The timing of postoperative mortality | The postoperative mortality of patients. | 6 weeks |
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