Viewing Study NCT03627325



Ignite Creation Date: 2024-05-06 @ 11:54 AM
Last Modification Date: 2024-10-26 @ 12:51 PM
Study NCT ID: NCT03627325
Status: COMPLETED
Last Update Posted: 2018-08-13
First Post: 2018-07-25

Brief Title: The Difference in Preoperative Evaluation That is Given by a Senior Physician a Specialist and a Computer Program
Sponsor: Western Galilee Hospital-Nahariya
Organization: Western Galilee Hospital-Nahariya

Study Overview

Official Title: Differences in Surgical Risk Evaluation by Surgical Risk Calculator Residents and Senior Anesthesiologists
Status: COMPLETED
Status Verified Date: 2018-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ACS
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 operations1 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 Patients 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None