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

Surgery Clinical Trial

— ACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627325
• Other study ID #: NHR-14-OR-0094
• Status: Completed
• Start date: October 2, 2014
• Est. completion date: August 15, 2016

Study information

• Verified date: August 2018
• Source: Western Galilee Hospital-Nahariya
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 15, 2016
• Est. primary completion date: August 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients candidates for surgery

• Signed informed consent by patient

Exclusion Criteria:

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• Patients who are scheduled for any surgical procedure
looking for correlation for estimating the complications between the anesthesiologists and the computerized method.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.