SurgeryNCT04386733
Same-day Cardiac Surgery Cancellation
An observational study of Surgery, run by St. Bartholomew's Hospital at 1 site in United Kingdom.
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.
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 group | Role | What they receive |
|---|---|---|
| Cancelled | all 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-cancelled | all 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.
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
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)
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.
- First posted13 May 2020
- Study start1 Aug 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- St. Bartholomew's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Jasionowska, St. Bartholomew's Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Surgery Cancellation at a Large UK Centre and Patient Satisfaction Survey - Quality Improvement Study
- ClinicalTrials.gov ID
- NCT04386733
- Conditions
- Surgery
- Keywords
- surgery cancellation, cardiac surgery, service improvement, patient satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,388 participants (actual)
- Lead sponsor
- St. Bartholomew's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 8 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancelled | – | Other: no intervention, it was an observational study which looked at the reasons for surgical cancellationsall adult patients whose surgery was cancelled on the day of the planned procedure |
| Non-cancelled | – | Other: no intervention, it was an observational study which looked at the reasons for surgical cancellationsall adult patients whose surgery was not cancelled on the day of the planned procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients whose cardiac surgeries were scheduled at the St.Bartholomew's hospital during the study period
Key inclusion criteria (1 listed)
- adult patients who were scheduled for elective or urgent cardiac surgery
Key exclusion criteria (1 listed)
- patients under the age of 18 or scheduled for an emergency cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention, it was an observational study which looked at the reasons for surgical cancellationsthe investigators observed how many patients had their surgeries cancelled and analysed the reasons of these cancellations | Other | Cancelled, Non-cancelled |
Primary outcome
Frequency of cancelled cardiac surgery assessed by number of cancellations
Time frame: immediately after the cancellation of the same-day surgery
frequency and reason for same-day cancellations
Reasons for cancellation of cardiac surgery
Time frame: immediately after the cancellation of the same-day surgery
reasons for cancelled cardiac surgeries were checked in patients notes and recorded
1 secondary outcome
Patient's satisfaction and reaction to the cancellation assessed by the Patient Satisfaction Questionnaire
Time frame: throughout study completion, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.