Evaluation of the ACS-NSQIP Risk Calculator for Emergent Surgery in a Spanish Population

NCT04211532 | Unknown

• 1 other identifier: CSPT-CIR-MP-ACSCalc
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Complications

Keywords

Surgical risk; ACS NSQIP

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  30 days

Interventions

Surgery OTHER

Surgical risk is calculated according to the surgery performed.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any patient who underwent emergent surgery is going to be recruited in the study.

You may qualify if:

• 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.

You may not qualify if:

• Patients who activated of the polytraumatic code.
• Patients with proctologic disease.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Mireia Pascua Solé

Sabadell, 08208, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 30777277 BACKGROUND

• Copeland 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.

  PMID: 2021856 BACKGROUND

• Havens 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.

  PMID: 29766138 BACKGROUND

• Bilimoria 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.

  PMID: 24055383 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 26, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: December 26, 2019

Record last verified: 2019-12

Locations

ES (1)