The Difference in Preoperative Evaluation That is Given by a Senior Physician, a Specialist, and a Computer Program (ACS)

Differences in Surgical Risk Evaluation by Surgical Risk Calculator, Residents and Senior Anesthesiologists

There is an increasing need and interest in being able to empirically estimate customized, patient-specific risks for virtually all surgical operations in a user-friendly format.

The ACS (American College of Surgeons) surgical risk calculator is a decision-support tool based on reliable multi institutional clinical data, which can be used to estimate the risks of most operations.1 The aim of this study is to compare the assessment provided by the The ACS Surgical Risk Calculator with the assessment provided by a senior and a resident anesthesiologist, and by that comparison to establish the need for the ACS calculator

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Other: Patients who are scheduled for any surgical procedure

Detailed Description

Understanding the risks of surgery is clearly important for both patients and surgeons in the shared decision making process. Informed consent requires that patients have a thorough understanding of the potential risks of surgery. Moreover, clinicians and patients also need information regarding surgical risks in order to make decisions on the type of operation or whether surgery should be performed at all.

Therefore, there is a need to discuss the risks derived empirically with a specific patient before any action to guide both surgical decision-making and informed consent.

However, predicting postoperative risks and identifying patients at a higher risk of adverse events have traditionally been based on individual surgeon experience and augmented by published rates in the literature, either from single institution studies or clinical trials. Unfortunately, these estimates are typically not specific to an individual Patient's risk factors. The ACS (American College of Surgeons) Surgical Risk Calculator estimates the chance of an unfavorable outcome (such as a complication or death) after surgery. The risk is estimated based upon information the patient gives to the healthcare provider about prior health history. The estimates are calculated using data from a large number of patients who had a surgical procedure similar to the one the patient may have.

• Study Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who are scheduled for any surgical procedure will be recruited for the study

Description

Inclusion Criteria:

• Patients candidates for surgery
• Signed informed consent by patient

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity for each patient	Anesthesiologists give their estimation of overall mortality that is compared to that given by the ACS web-based calculator	Each patient is assessed within a week by both physicians and the ACS web-based computer. The trial is scheduled for a whole year.
Morbidity for each patient	Anesthesiologists give their estimation of different morbidities and that is compared to that given by the ACS web-based calculator	Each patient is assessed within a week by both physicians and the ACS web-based computer. The trial is scheduled for a whole year.

Collaborators and Investigators

• Sponsor: Western Galilee Hospital-Nahariya

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2014
• Primary Completion (Actual): August 15, 2016
• Study Completion (Actual): August 15, 2016

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: NHR-14-OR-0094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: there is no plan to make individual participant data available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No