NCT03627325

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

1.9 years

First QC Date

July 25, 2018

Last Update Submit

August 9, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

Interventions

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients candidates for surgery
  • Signed informed consent by patient

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Head and Neck Surgery Unit

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 13, 2018

Study Start

October 2, 2014

Primary Completion

August 15, 2016

Study Completion

August 15, 2016

Last Updated

August 13, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

there is no plan to make individual participant data available to other researchers