Postoperative ComplicationsNCT04211532
Evaluation of the ACS-NSQIP Risk Calculator for Emergent Surgery in a Spanish Population
An observational study of Postoperative Complications, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Nowadays, quality of life and individualised medicine are becoming more important in the everyday medical practice and surgery it is not an exception. In recent years, the interest in the improvement of the quality of surgical procedures and outcomes has increased. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Surgery
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2019to 1 Jun 2020
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient who underwent emergent surgery is going to be recruited in the study.
Who may be able to join
- Patients recruited were aged 18 years and older.
- Those who underwent emergency (immediate and urgent) surgery in Hospital Universitari Parc Taulí from June 2019 to June 2020.
Who cannot join
- Patients who activated of the polytraumatic code.
- Patients with proctologic disease.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Mireia Pascua Solé
Sabadell, 08208
Mireia Pascua Solé, mireiapascua@gmail.com
Pere Rebasa-Cladera
About this study
Nowadays, quality of life and individualised medicine are becoming more important in the everyday medical practice and surgery it is not an exception. In recent years, the interest in the improvement of the quality of surgical procedures and outcomes has increased. This quality can be improved by assessing the surgical or operative risk by evaluating the postoperative mortality and morbidity.
Most of the risk stratification tools are used in elective surgery. Only few have been specifically validated for immediate or urgent. However, there are different situations. In elective interventions, the patient and the surgeon can discuss the advantages and drawbacks and postpone the decision. Moreover, an improvement in the physical status of the patient can be performed whereas in immediate or urgent surgery there is no time to neither of them.
Read more
POSSUM is used as the main tool for the prediction of mortality and morbidity and for assessing the quality care of the General Surgery Unit of Corporació Sanitària Parc Taulí. Nevertheless, this system has its limitations. It overestimates mortality in low risk patients and it does not take into account the specific surgical procedure.
That is why, it is believed that the ACS-NSQIP risk calculator -created in 2013- is a potential good tool to stratify surgical risks. In contrast with POSSUM, it considers any surgical procedure -according to the Current Procedural Terminology.
The calculator has been externally validated in population of North-America which requires emergent surgery with a somewhat underestimation of the risk. As populations have different profiles and there are different levels of care, it is needed the external validation in other countries.
In essence, there is a need of validation of risk calculators in different populations and emergency surgery (immediate and urgent) is distinct from the elective operation, therefore they should be considered separately when risk is calculated.
Therefore, there is a need of validation of the ACS NSQIP risk calculator in Spanish population which requires emergency (immediate and urgent) surgery. On the other hand, it is suggested that ACS NSQIP risk calculator performs better than POSSUM . Hence, its prediction performance is compared with POSSUM.
Read the detailed description
A prospective validation cohort study is proposed. The surgical risk of the patients recruited in the study was calculated by the ACS NSQIP risk calculator and by POSSUM.
In order to compare the performance of ACS NSQIP risk calculator with POSSUM, area under the receiver operating characteristic curve (AUC) was calculated for each tool. The statistical differences between the two AUC curves were compared using P value. Calibration of the agreement between observed and predicted outcomes was tested using the Brier score. The Brier score ranges from 0 to 1. The closer the score is to 0, the more accurate is the risk prediction model.
There is a need of validation of the ACS NSQIP risk calculator in Spanish population which requires emergency (immediate and urgent) surgery. Besides, it is suggested that ACS NSQIP risk calculator performs better than POSSUM. Hence, its prediction performance is compared with POSSUM.
- Conditions
- Postoperative Complications
- Being tested
- Surgery
- Keywords
- Surgical risk, ACS NSQIP
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryOther
Surgical risk is calculated according to the surgery performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
ACS NSQIP outcomes
Each probability of the different outcomes calculated and described by the ACS NSQIP. These outcomes are the probability of suffering from: serious complication, any complication, pneumonia, cardiac complication, surgical site infection, urinary tract infection, venous thromboembolism, renal failure, ileus, anastomotic leak, return to operating room, discharge to post-acute care and death.
Measured: 30 days
POSSUM outcomes
Each probability of the different outcomes calculated by POSSUM. These outcomes are the probability of suffering from the outcomes described for ACS NSQIP.
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 Dec 2019
- Study start1 Jun 2019
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mireia Pascua-Solé, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211532
- Sponsor's protocol ID
- CSPT-CIR-MP-ACSCalc
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Did we prioritize quality improvement in general surgery: Time for a focus on outcomes and enhanced recovery care plans. Am J Surg. 2019 Mar;217(3):539-540. doi: 10.1016/j.amjsurg.2018.12.049. No abstract available.
PubMed 30777277Copeland GP, Jones D, Walters M. POSSUM: a scoring system for surgical audit. Br J Surg. 1991 Mar;78(3):355-60. doi: 10.1002/bjs.1800780327.
PubMed 2021856Havens JM, Columbus AB, Seshadri AJ, Brown CVR, Tominaga GT, Mowery NT, Crandall M. Risk stratification tools in emergency general surgery. Trauma Surg Acute Care Open. 2018 Apr 29;3(1):e000160. doi: 10.1136/tsaco-2017-000160. eCollection 2018.
PubMed 29766138Bilimoria KY, Liu Y, Paruch JL, Zhou L, Kmiecik TE, Ko CY, Cohen ME. Development and evaluation of the universal ACS NSQIP surgical risk calculator: a decision aid and informed consent tool for patients and surgeons. J Am Coll Surg. 2013 Nov;217(5):833-42.e1-3. doi: 10.1016/j.jamcollsurg.2013.07.385. Epub 2013 Sep 18.
PubMed 24055383
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the ACS-NSQIP Risk Calculator for Emergent Surgery in a Spanish Population
- ClinicalTrials.gov ID
- NCT04211532
- Acronym / sponsor ID
- CSPT-CIR-MP-ACSCalc
- Conditions
- Postoperative Complications
- Keywords
- Surgical risk, ACS NSQIP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 26 Dec 2019 (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.
Nowadays, quality of life and individualised medicine are becoming more important in the everyday medical practice and surgery it is not an exception. In recent years, the interest in the improvement of the quality of surgical procedures and outcomes has increased. This quality can be improved by assessing the surgical or operative risk by evaluating the postoperative mortality and morbidity.
Most of the risk stratification tools are used in elective surgery. Only few have been specifically validated for immediate or urgent. However, there are different situations. In elective interventions, the patient and the surgeon can discuss the advantages and drawbacks and postpone the decision. Moreover, an improvement in the physical status of the patient can be performed whereas in immediate or urgent surgery there is no time to neither of them.
POSSUM is used as the main tool for the prediction of mortality and morbidity and for assessing the quality care of the General Surgery Unit of Corporació Sanitària Parc Taulí. Nevertheless, this system has its limitations. It overestimates mortality in low risk patients and it does not take into account the specific surgical procedure.
That is why, it is believed that the ACS-NSQIP risk calculator -created in 2013- is a potential good tool to stratify surgical risks. In contrast with POSSUM, it considers any surgical procedure -according to the Current Procedural Terminology.
The calculator has been externally validated in population of North-America which requires emergent surgery with a somewhat underestimation of the risk. As populations have different profiles and there are different levels of care, it is needed the external validation in other countries.
In essence, there is a need of validation of risk calculators in different populations and emergency surgery (immediate and urgent) is distinct from the elective operation, therefore they should be considered separately when risk is calculated.
Therefore, there is a need of validation of the ACS NSQIP risk calculator in Spanish population which requires emergency (immediate and urgent) surgery. On the other hand, it is suggested that ACS NSQIP risk calculator performs better than POSSUM . Hence, its prediction performance is compared with POSSUM.
Detailed description
A prospective validation cohort study is proposed. The surgical risk of the patients recruited in the study was calculated by the ACS NSQIP risk calculator and by POSSUM.
In order to compare the performance of ACS NSQIP risk calculator with POSSUM, area under the receiver operating characteristic curve (AUC) was calculated for each tool. The statistical differences between the two AUC curves were compared using P value. Calibration of the agreement between observed and predicted outcomes was tested using the Brier score. The Brier score ranges from 0 to 1. The closer the score is to 0, the more accurate is the risk prediction model.
There is a need of validation of the ACS NSQIP risk calculator in Spanish population which requires emergency (immediate and urgent) surgery. Besides, it is suggested that ACS NSQIP risk calculator performs better than POSSUM. Hence, its prediction performance is compared with POSSUM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient who underwent emergent surgery is going to be recruited in the study.
Key inclusion criteria (2 listed)
- Patients recruited were aged 18 years and older.
- Those who underwent emergency (immediate and urgent) surgery in Hospital Universitari Parc Taulí from June 2019 to June 2020.
Key exclusion criteria (2 listed)
- Patients who activated of the polytraumatic code.
- Patients with proctologic disease.
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 |
|---|---|---|
| SurgerySurgical risk is calculated according to the surgery performed. | Other | – |
Primary outcome
ACS NSQIP outcomes
Time frame: 30 days
Each probability of the different outcomes calculated and described by the ACS NSQIP. These outcomes are the probability of suffering from: serious complication, any complication, pneumonia, cardiac complication, surgical site infection, urinary tract infection, venous thromboembolism, renal failure, ileus, anastomotic leak, return to operating room, discharge to post-acute care and death.
POSSUM outcomes
Time frame: 30 days
Each probability of the different outcomes calculated by POSSUM. These outcomes are the probability of suffering from the outcomes described for ACS NSQIP.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Background: PubMed 30777277Did we prioritize quality improvement in general surgery: Time for a focus on outcomes and enhanced recovery care plans. Am J Surg. 2019 Mar;217(3):539-540. doi: 10.1016/j.amjsurg.2018.12.049. No abstract available.
- Background: PubMed 2021856Copeland GP, Jones D, Walters M. POSSUM: a scoring system for surgical audit. Br J Surg. 1991 Mar;78(3):355-60. doi: 10.1002/bjs.1800780327.
- Background: PubMed 29766138Havens JM, Columbus AB, Seshadri AJ, Brown CVR, Tominaga GT, Mowery NT, Crandall M. Risk stratification tools in emergency general surgery. Trauma Surg Acute Care Open. 2018 Apr 29;3(1):e000160. doi: 10.1136/tsaco-2017-000160. eCollection 2018.
- Background: PubMed 24055383Bilimoria KY, Liu Y, Paruch JL, Zhou L, Kmiecik TE, Ko CY, Cohen ME. Development and evaluation of the universal ACS NSQIP surgical risk calculator: a decision aid and informed consent tool for patients and surgeons. J Am Coll Surg. 2013 Nov;217(5):833-42.e1-3. doi: 10.1016/j.jamcollsurg.2013.07.385. Epub 2013 Sep 18.
- ACS Risk CalculatorLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
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 Postoperative Complications, run by Corporacion Parc Tauli at 1 site in Spain.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Dec 2019. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACS NSQIP outcomes (time frame: 30 days). 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?
On the ClinicalTrials.gov record for NCT04211532, which also lists 4 linked publications.
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 26 Dec 2019.