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OpenTrials
Completed

NCT Number: NCT03627325

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

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

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Key information

Conditions

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients candidates for surgery
  • Signed informed consent by patient

Exclusion criteria

  • None

Treatment and study plan

Patients who are scheduled for any surgical procedure

Other

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

Primary outcomes

  1. Morbidity for each patient

    Time frame: Each patient is assessed within a week by both physicians and the ACS web-based computer. The trial is scheduled for a whole year.

    Anesthesiologists give their estimation of overall mortality that is compared to that given by the ACS web-based calculator

  2. Morbidity for each patient

    Time frame: Each patient is assessed within a week by both physicians and the ACS web-based computer. The trial is scheduled for a whole year.

    Anesthesiologists give their estimation of different morbidities and that is compared to that given by the ACS web-based calculator

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Registry information

Official study title

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

Acronym: ACS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 13, 2018
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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