Prediction of Morbidity and Mortality With Medical Pre-Operative Fitness Assessment

May 28, 2023 updated by: Yasmeen Abdelshafy Ebrahim, Assiut University
Aim to measure the predictability of medical pre -Operative Fitness Assessment to the actual rates of morbidity and mortality related to surgery in Assiut university Hospital.

Study Overview

Status

Not yet recruiting

Detailed Description

Perioperative morbidity and mortality remain the mostly important barrier to surgical interventions worldwide. Therefor, decision making relies upon accurate risk Assessment to be balanced with hoped benefit.

For elective surgeries, multiple clinical tools have been used to Assessment perioperative Fitness, but with limited applicability. For instance, the american society of anesthesiologists phesical status score (ASA-PS) does not consider the type of surgery, nor the patient's age.

The physiological and Operative severity score for the enumeration of mortality (POSSUM) evaluates the intra-operative difficulties, limiting the preoperative prediction.

Recently, researchers layer and his colleagues at University Hospital Bonn, modified the preoperative score to Predict Postoperative Mortality (POSPOM) to be applied in daily practice.

In investigator 's practice, Assiut university Hospitals already have a Pre-Operative Fitness Assessment (POFA) clinical and investigator aim to adapt and evaluate the POSPOM system in investigator' s practice.

Study Type

Observational

Enrollment (Estimated)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adults >18 Inclusion Criteria:

  • Adults (>18 years old ) preparing for elective intervention

Description

Inclusion Criteria:

  • Adults (>18 years old ) preparing for elective intervention.

Exclusion Criteria:

  • those who do not require anaesthesia Those who did not undergo surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidance of 22 adverse events according to the Eurepian perioperative clinical outcom definitions
Time Frame: Baseline
Follow up of preoperative medically diseased patients after surgery to detect outcoms
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 28, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

May 28, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • mPOFA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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