Clinical trial NCT05892796: Prediction of Morbidity and Mortality With Medical Pre-Operative Fitness Assessment
Official title: Prediction of Morbidity and Mortality With Medical Pre-Operative Fitness Assessment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perioperative Medical Fitness Assessment
Keywords: Fitness Assessment
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults \>18 Inclusion Criteria:

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

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Incidance of 22 adverse events according to the Eurepian perioperative clinical outcom definitions
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Conrad C, Eltzschig HK. Disease Mechanisms of Perioperative Organ Injury. Anesth Analg. 2020 Dec;131(6):1730-1750. doi: 10.1213/ANE.0000000000005191.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.