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

NCT ID: NCT05892796

Last Updated: 2023-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-30

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Perioperative Medical Fitness Assessment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* those who do not require anaesthesia Those who did not undergo surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yasmeen Abdelshafy Ebrahim

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yasmin AbdElshafy Ebrahim

Role: CONTACT

01558124229

Mohammad Hasan Mohammad

Role: CONTACT

01115353591

References

Explore related publications, articles, or registry entries linked to this study.

Conrad C, Eltzschig HK. Disease Mechanisms of Perioperative Organ Injury. Anesth Analg. 2020 Dec;131(6):1730-1750. doi: 10.1213/ANE.0000000000005191.

Reference Type BACKGROUND
PMID: 33186161 (View on PubMed)

Eyob B, Boeck MA, FaSiOen P, Cawich S, Kluger MD. Ensuring safe surgical care across resource settings via surgical outcomes data & quality improvement initiatives. Int J Surg. 2019 Dec;72S:27-32. doi: 10.1016/j.ijsu.2019.07.036. Epub 2019 Aug 5.

Reference Type BACKGROUND
PMID: 31394278 (View on PubMed)

Sankar A, Johnson SR, Beattie WS, Tait G, Wijeysundera DN. Reliability of the American Society of Anesthesiologists physical status scale in clinical practice. Br J Anaesth. 2014 Sep;113(3):424-32. doi: 10.1093/bja/aeu100. Epub 2014 Apr 11.

Reference Type BACKGROUND
PMID: 24727705 (View on PubMed)

Copeland GP, Jones D, Walters M. POSSUM: a scoring system for surgical audit. Br J Surg. 1991 Mar;78(3):355-60. doi: 10.1002/bjs.1800780327.

Reference Type BACKGROUND
PMID: 2021856 (View on PubMed)

Le Manach Y, Collins G, Rodseth R, Le Bihan-Benjamin C, Biccard B, Riou B, Devereaux PJ, Landais P. Preoperative Score to Predict Postoperative Mortality (POSPOM): Derivation and Validation. Anesthesiology. 2016 Mar;124(3):570-9. doi: 10.1097/ALN.0000000000000972.

Reference Type BACKGROUND
PMID: 26655494 (View on PubMed)

Layer YC, Menzenbach J, Layer YL, Mayr A, Hilbert T, Velten M, Hoeft A, Wittmann M. Validation of the Preoperative Score to Predict Postoperative Mortality (POSPOM) in Germany. PLoS One. 2021 Jan 27;16(1):e0245841. doi: 10.1371/journal.pone.0245841. eCollection 2021.

Reference Type BACKGROUND
PMID: 33503043 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

mPOFA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.