Postoperative CareSASNCT01799369
Surgical Apgar Score in Clinical Practice: a Pilot Study
A study testing Surgical Apgar Score in people with Postoperative Care, run by London Surgical Research Group.
Trial summary
Background Surgeons lack a routine, objective evaluation of patient condition after surgery. We currently rely on subjective assessment of available patient data. The current scoring methods such as Acute Physiology and Chronic Health Evaluation and Physiological and Operative Severity Score for the enUmeration of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Care
- What is being tested?
- Surgical Apgar Score
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Oct 2012
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18y+)
- General or vascular surgery
- Elective or emergency surgery
- Routine outpatient follow-up required
Who cannot join
- Those without capacity to consent to involvement in the trial
About this study
Background Surgeons lack a routine, objective evaluation of patient condition after surgery. We currently rely on subjective assessment of available patient data. The current scoring methods such as Acute Physiology and Chronic Health Evaluation and Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity are complex and cumbersome and have therefore not been adopted into routine practice.
The Surgical Apgar Score (SAS) is a simple score on a scale of 0 to 10 calculated from 3 parameters collected during the operation: lowest heart rate, lowest blood pressure, estimated blood loss (Regenbogen et al., Arch Surg 2009).
Read more
Previous validation studies have shown a good correlation between the score and incidence of major complications or death occurring within 30 days. For example, 75% patients with a score of 0-2 had major complications, whereas it was only 5% in those with a score of 9-10. To date, the SAS has never been clinically applied and tested in a trial.
We believe that routine use of the SAS will lead to a reduction in major complications and deaths after surgery. We also believe that it will lead to a reduction in the severity of the complications.
This is based on our theory that the SAS eliminates the guesswork. Using this score will add objectivity and clarity to clinical decisions that are presently based on clinical instinct or 'gut feeling'. The score will more clearly highlight those patients who are at an increased risk of developing complications or dying and will flag them up for increased monitoring, a higher index of clinical suspicion and a lower threshold for early management of problems.
Primary Aim The primary aim of the pilot is to strengthen the design and assess the feasibility of the main study on the SAS. We aim to recruit 100 patients in each group, 200 in total. The primary aim of the main study will be to establish if clinical application of the SAS leads to a reduction in 30-day post-operative morbidity and mortality.
Study Design The design of this pilot is the same as what the main trial will eventually be: a multicentre single-blind randomised controlled trial (RCT). Current data suggests the overall expected major complication or death rate in our target population would be 21%. The sample size of the future RCT is therefore estimated to be 986 each group to detect a 5% reduction in complications (Significance 0.05%, Power 80%).
Outcomes Our primary outcome will be major complications or death within 30 days of operation. Our secondary outcomes (all within 30 days of operation) will be minor complications, primary and secondary critical care admissions and length of stay, duration of therapeutic antibiotics, number of additional operations under general anaesthetic to treat complications, and overall length of stay.
- Conditions
- Postoperative Care
- Being tested
- Surgical Apgar Score
- Keywords
- Surgical Apgar Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Apgar ScoreBehavioural
Post-operative care influenced by Surgical Apgar Score
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Routine post-operative care |
| Intervention | Experimental | Post-operative care influenced by the Surgical Apgar Score Receives: Behavioral: Surgical Apgar Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complications or death
Composite binary outcome
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startApr 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative CareStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Surgical Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Responsible party
- Sponsor
- Investigators
- James B Haddow, MRCS, Study chair, London Surgical Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799369
- Sponsor's protocol ID
- LSRG-001
- Acronym
- SAS
- Status last verified
- Mar 2016
- First submitted
- 23 Feb 2013
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Haddow JB, Adwan H, Clark SE, Tayeh S, Antonowicz SS, Jayia P, Chicken DW, Wiggins T, Davenport R, Kaptanis S, Fakhry M, Knowles CH, Elmetwally AS, Geddoa E, Nair MS, Naeem I, Adegbola S, Muirhead LJ; London Surgical Research Group. Use of the surgical Apgar score to guide postoperative care. Ann R Coll Surg Engl. 2014 Jul;96(5):352-8. doi: 10.1308/003588414X13946184900840.
PubMed 24992418
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Apgar Score in Clinical Practice: a Pilot Study
- ClinicalTrials.gov ID
- NCT01799369
- Acronym / sponsor ID
- SAS / LSRG-001
- Conditions
- Postoperative Care
- Keywords
- Surgical Apgar Score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- London Surgical Research GroupUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Study start
- Apr 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 26 Feb 2013 (estimated)
- 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.
Background Surgeons lack a routine, objective evaluation of patient condition after surgery. We currently rely on subjective assessment of available patient data. The current scoring methods such as Acute Physiology and Chronic Health Evaluation and Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity are complex and cumbersome and have therefore not been adopted into routine practice.
The Surgical Apgar Score (SAS) is a simple score on a scale of 0 to 10 calculated from 3 parameters collected during the operation: lowest heart rate, lowest blood pressure, estimated blood loss (Regenbogen et al., Arch Surg 2009).
Previous validation studies have shown a good correlation between the score and incidence of major complications or death occurring within 30 days. For example, 75% patients with a score of 0-2 had major complications, whereas it was only 5% in those with a score of 9-10. To date, the SAS has never been clinically applied and tested in a trial.
We believe that routine use of the SAS will lead to a reduction in major complications and deaths after surgery. We also believe that it will lead to a reduction in the severity of the complications.
This is based on our theory that the SAS eliminates the guesswork. Using this score will add objectivity and clarity to clinical decisions that are presently based on clinical instinct or 'gut feeling'. The score will more clearly highlight those patients who are at an increased risk of developing complications or dying and will flag them up for increased monitoring, a higher index of clinical suspicion and a lower threshold for early management of problems.
Primary Aim The primary aim of the pilot is to strengthen the design and assess the feasibility of the main study on the SAS. We aim to recruit 100 patients in each group, 200 in total. The primary aim of the main study will be to establish if clinical application of the SAS leads to a reduction in 30-day post-operative morbidity and mortality.
Study Design The design of this pilot is the same as what the main trial will eventually be: a multicentre single-blind randomised controlled trial (RCT). Current data suggests the overall expected major complication or death rate in our target population would be 21%. The sample size of the future RCT is therefore estimated to be 986 each group to detect a 5% reduction in complications (Significance 0.05%, Power 80%).
Outcomes Our primary outcome will be major complications or death within 30 days of operation. Our secondary outcomes (all within 30 days of operation) will be minor complications, primary and secondary critical care admissions and length of stay, duration of therapeutic antibiotics, number of additional operations under general anaesthetic to treat complications, and overall length of stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Routine post-operative care |
| Intervention | Experimental | Behavioral: Surgical Apgar ScorePost-operative care influenced by the Surgical Apgar Score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (18y+)
- General or vascular surgery
- Elective or emergency surgery
- Routine outpatient follow-up required
Key exclusion criteria (1 listed)
- Those without capacity to consent to involvement in the trial
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 |
|---|---|---|
| Surgical Apgar ScorePost-operative care influenced by Surgical Apgar Score | Behavioural | Intervention |
Primary outcome
Major complications or death
Time frame: 30 days
Composite binary outcome
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 8 Mar 2016.
- Results publication: PubMed 24992418Haddow JB, Adwan H, Clark SE, Tayeh S, Antonowicz SS, Jayia P, Chicken DW, Wiggins T, Davenport R, Kaptanis S, Fakhry M, Knowles CH, Elmetwally AS, Geddoa E, Nair MS, Naeem I, Adegbola S, Muirhead LJ; London Surgical Research Group. Use of the surgical Apgar score to guide postoperative care. Ann R Coll Surg Engl. 2014 Jul;96(5):352-8. doi: 10.1308/003588414X13946184900840.
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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.
James B Haddow, MRCS study chair
London Surgical Research Group
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Apgar Score in people with Postoperative Care, run by London Surgical Research Group.
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 4 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 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Major complications or death (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01799369, which also lists 1 linked publication.
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 8 Mar 2016; AzTrials last refreshed its copy on 30 Oct 2026.