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SurgeryNCT04386733

Same-day Cardiac Surgery Cancellation

An observational study of Surgery, run by St. Bartholomew's Hospital at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators prospectively reviewed all same-day cancellations of elective and urgent in-patient adult cardiac surgical procedures from August 2017 to March 2018. Patients were divided into two groups: cancelled (C) and not cancelled (NC). Qualitative patient satisfaction survey was also undertaken. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Surgery
How many people
1,388 participants
Where
1 siteUnited Kingdom
Study dates
1 Aug 2017to 31 Mar 2018
How long will I take part?
8 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adult patients whose cardiac surgeries were scheduled at the St.Bartholomew's hospital during the study period

Who may be able to join

  • adult patients who were scheduled for elective or urgent cardiac surgery

Who cannot join

  • patients under the age of 18 or scheduled for an emergency cardiac surgery

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • St Bartholomew's Hospital

    London

Other trials in United Kingdom

About this study

Official title: Cardiac Surgery Cancellation at a Large UK Centre and Patient Satisfaction Survey - Quality Improvement Study

The investigators prospectively reviewed all same-day cancellations of elective and urgent in-patient adult cardiac surgical procedures from August 2017 to March 2018. Patients were divided into two groups: cancelled (C) and not cancelled (NC). Qualitative patient satisfaction survey was also undertaken.

Read the detailed description

This prospective audit was performed over a 7-month period (August - March 2018). A quality improvement team, consisting of two clinical research fellows and a consultant cardiothoracic surgeon, reviewed all the cancellations. The research is reported in line with the Standards for Quality Improvement Reporting Excellence (SQUIRE) guidelines.

Adult patients undergoing elective and urgent cardiac surgery were included in our study. Those who underwent emergency or non-cardiac procedures and patients under the age of 18 were excluded. Patients were identified on a weekly basis from theatre registers and printed operating lists. Same day surgery cancellations were defined as any postponement of patients' operation once listed for surgery.

Electronic hospital records were reviewed, and the following information was recorded for all patients: demographics; scheduled surgery date; euroSCORE II and its components; admission type (elective/urgent in-house/transfer patient); date of pre-operative anaesthetic review. Additionally, reasons for cancellation, timing of cancellation (pre-operative/during anaesthesia/intraoperative) and outcomes were recorded. Outcomes included: time from cancellation to performed operation; hospital stay post-cancellation and mortality. Patients were divided into cancelled (C) and non-cancelled (NC) groups for analysis.

The reasons for cancellation were categorized into: lack of ITU beds and nurses; patient medically unfit; scheduling error; patient-related issues; emergency intervened; procedure no longer needed; lack of perfusionist; incomplete investigations; surgeon unavailable; transfer issue; theatre staff shortage; electrical system failure; new intra-operative TOE findings. Patient-related issues included failure to stop medication and treatment refusal. Scheduling errors included overrunning cases, overbooking of the operating room, late operation start and IT errors.

The investigators further assessed the impact of cancellations on patient satisfaction and wellbeing. Patients completed a questionnaire by telephone at 3 months after discharge to allow time to reflect. Questionnaire data assessed adherence to Association of Anaesthetists of Great Britain and Ireland Theatre Efficiency guidance, including healthcare professional informing patients; time offered for explanation; patient understanding and satisfaction as well as perception of being kept nil by mouth (NBM) longer than necessary. (Figure 1) This questionnaire has previously been used by Wasim et al. to assess patient experience following cancelled orthopaedic surgery. A pilot study was conducted to trial the its' validity.

All data was entered into a Microsoft Excel spreadsheet. Statistical analysis consisted of determination of the mean and range for continuous data and percentage quantification for the categorical data. Statistical significance was established using chi-squared test and two-sided unpaired student t-test with p values <0.05 considered significant. The study was approved by the St Bartholomew's Trust Ethics and Quality Improvement Committee. As this was a quality improvement project and information collected did not include personal identifiers, individual consents were not required.

Conditions
Surgery
Being tested
no intervention, it was an observational study which looked at the reasons for surgical cancellations
Keywords
surgery cancellation, cardiac surgery, service improvement, patient satisfaction
Medical subject headings
Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no intervention, it was an observational study which looked at the reasons for surgical cancellationsOther

    the investigators observed how many patients had their surgeries cancelled and analysed the reasons of these cancellations

Study groups in NCT04386733
Study groupRoleWhat they receive
Cancelledall adult patients whose surgery was cancelled on the day of the planned procedure
Receives: Other: no intervention, it was an observational study which looked at the reasons for surgical cancellations
Non-cancelledall adult patients whose surgery was not cancelled on the day of the planned procedure
Receives: Other: no intervention, it was an observational study which looked at the reasons for surgical cancellations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of cancelled cardiac surgery assessed by number of cancellations

    frequency and reason for same-day cancellations

    Measured: immediately after the cancellation of the same-day surgery

  2. Reasons for cancellation of cardiac surgery

    reasons for cancelled cardiac surgeries were checked in patients notes and recorded

    Measured: immediately after the cancellation of the same-day surgery

Secondary outcomes (1)
  1. Patient's satisfaction and reaction to the cancellation assessed by the Patient Satisfaction Questionnaire

    evaluation of patient's reactions to cancellations

    Measured: throughout study completion, an average of 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2020
  2. Study start1 Aug 2017
  3. Primary completion31 Mar 2018
  4. Study completion31 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,388 participants (actual)
Target duration
8 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04386733
Status last verified
May 2020
First submitted
4 May 2020
Last updated
13 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery, run by St. Bartholomew's Hospital at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of cancelled cardiac surgery assessed by number of cancellations (time frame: immediately after the cancellation of the same-day surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020; AzTrials last refreshed its copy on 27 Oct 2026.

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