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

NCT ID: NCT03627325

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-02
• Study Completion Date: 2016-08-15

Brief 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

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.

Conditions

Surgery

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Patients who are scheduled for any surgical procedure

looking for correlation for estimating the complications between the anesthesiologists and the computerized method.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients candidates for surgery
• Signed informed consent by patient

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ronen Ohad

Director Head and Neck Surgery Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

NHR-14-OR-0094

Identifier Type: -

Identifier Source: org_study_id