Perioperative Medical Fitness AssessmentNCT05892796
Prediction of Morbidity and Mortality With Medical Pre-Operative Fitness Assessment
An observational study of Perioperative Medical Fitness Assessment, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Perioperative Medical Fitness Assessment
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Adults >18 Inclusion Criteria: * Adults (>18 years old ) preparing for elective intervention
Who may be able to join
- Adults (>18 years old ) preparing for elective intervention.
Who cannot join
- those who do not require anaesthesia Those who did not undergo surgery
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Perioperative Medical Fitness Assessment
- Keywords
- Fitness Assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidance of 22 adverse events according to the Eurepian perioperative clinical outcom definitions
Follow up of preoperative medically diseased patients after surgery to detect outcoms
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Perioperative Medical Fitness AssessmentStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmeen Abdelshafy Ebrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892796
- Sponsor's protocol ID
- mPOFA
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Conrad C, Eltzschig HK. Disease Mechanisms of Perioperative Organ Injury. Anesth Analg. 2020 Dec;131(6):1730-1750. doi: 10.1213/ANE.0000000000005191.
PubMed 33186161Eyob 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.
PubMed 31394278Sankar 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.
PubMed 24727705Copeland 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.
PubMed 2021856Le 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.
PubMed 26655494Layer 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.
PubMed 33503043
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Morbidity and Mortality With Medical Pre-Operative Fitness Assessment
- ClinicalTrials.gov ID
- NCT05892796
- Acronym / sponsor ID
- mPOFA
- Conditions
- Perioperative Medical Fitness Assessment
- Keywords
- Fitness Assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults >18 Inclusion Criteria: * Adults (>18 years old ) preparing for elective intervention
Key inclusion criteria (1 listed)
- Adults (>18 years old ) preparing for elective intervention.
Key exclusion criteria (1 listed)
- those who do not require anaesthesia Those who did not undergo surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Background: PubMed 33186161Conrad C, Eltzschig HK. Disease Mechanisms of Perioperative Organ Injury. Anesth Analg. 2020 Dec;131(6):1730-1750. doi: 10.1213/ANE.0000000000005191.
- Background: PubMed 31394278Eyob 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.
- Background: PubMed 24727705Sankar 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.
- Background: PubMed 2021856Copeland 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.
- Background: PubMed 26655494Le 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.
- Background: PubMed 33503043Layer 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Medical Fitness Assessment, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasmin AbdElshafy Ebrahim (01558124229, Ya415400@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidance of 22 adverse events according to the Eurepian perioperative clinical outcom definitions (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05892796, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.