- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05892796
Prediction of Morbidity and Mortality With Medical Pre-Operative Fitness Assessment
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yasmin AbdElshafy Ebrahim
- Phone Number: 01558124229
- Email: Ya415400@gmail.com
Study Contact Backup
- Name: Mohammad Hasan Mohammad
- Phone Number: 01115353591
- Email: mhmdifferrent@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
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
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- Conrad C, Eltzschig HK. Disease Mechanisms of Perioperative Organ Injury. Anesth Analg. 2020 Dec;131(6):1730-1750. doi: 10.1213/ANE.0000000000005191.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- mPOFA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Perioperative Medical Fitness Assessment
-
Chang Gung Memorial HospitalUnknownHemodynamic Monitoring | Perioperative Care | Outcome Assessment
-
Liverpool John Moores UniversityUniversity of Central Lancashire; Queen's University, Belfast; Newcastle University and other collaboratorsCompletedMedical Education | Health Education | Educational AssessmentUnited Kingdom
-
Assistance Publique - Hôpitaux de ParisCompletedGlobal Medical Assessment of Elderly Frail PatientsFrance
-
Martin BrüngerAssociation nationale pour le développement de la qualité dans les hôpitaux...CompletedNeurologic Disorder | Observational Study | Assessment | Functional Independence | ICF | Medical Rehabilitation
-
University of KwaZuluUniversity of Cape Town; African Perioperative Research Group (APORG); Safe Surgery...CompletedSurgery | Perioperative/Postoperative Complications | Perioperative Outcomes | Outcome Assessment | Prospective Studies | Paediatrics | Hospital Mortality | Paediatric Surgery | Developing CountriesSouth Africa, Sudan
-
Dalarna County Council, SwedenCounty Council of Halland, SwedenUnknownAssessment | Emergency Medical Service | Registered NurseSweden
-
Queen Elizabeth II Health Sciences CentreCompletedCraniocerebral Trauma | Emergency Medical Services | Outcome Assessment (Health Care) | Brain Injuries,Traumatic | Organizational Innovation