Surgical Risk AssessmentNCT07454564
Preoperative Cardiac Power Output and P-POSSUM Score
An observational study of Surgical Risk Assessment and Postoperative Mortality, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the relationship between preoperative Cardiac Power Output (CPO), which reflects the pumping capacity of the heart, and the P-POSSUM score, a widely used surgical risk assessment tool, in patients aged 65 years and older undergoing abdominal surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Surgical Risk Assessment, Postoperative Mortality, Postoperative Morbidity
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2026to 30 Nov 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: This study will include patients aged 65 and over who are scheduled for abdominal surgery at Necmettin Erbakan University Faculty of Medicine Hospital.
Who may be able to join
- Undergoing abdominal surgery in general surgery practice (including elective and emergency procedures),
- ASA (American Society of Anesthesiologists) class I-III,
- Adequate recording with transthoracic echocardiography,
- Having given informed consent.
- Exclusion Criteria:Advanced heart failure with ejection fraction (EF) <30%,
- Severe valvular disease (severe stenosis or insufficiency),
Show all 9Show fewer
- Unstable coronary artery disease or recent myocardial infarction (within the last 3 months),
- Pulmonary hypertension,
- Severe arrhythmia (uncontrolled atrial fibrillation, ventricular tachycardia, etc.)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Necmettin Erbakan University
Konya
Engin Kılınç, medical doctor, 00 90 332 223 60 00, enginkilinc96@gmail.com
About this study
Official title: Investigation of the Relationship Between Preoperative Cardiac Power Output and P-POSSUM Score
This study aims to investigate the relationship between preoperative Cardiac Power Output (CPO), which reflects the pumping capacity of the heart, and the P-POSSUM score, a widely used surgical risk assessment tool, in patients aged 65 years and older undergoing abdominal surgery. Simple and non-invasive measurements performed in the preoperative period will be used to obtain CPO values and to evaluate whether these measurements are helpful in predicting postoperative morbidity and mortality. No additional procedures beyond routine clinical care will be performed as part of this observational study. The findings of this study may contribute to a more accurate assessment of surgical risk and help improve patient safety in the perioperative period.
Read the detailed description
This is a prospective, observational study designed to evaluate the relationship between preoperative Cardiac Power Output (CPO) and the P-POSSUM risk score in patients aged 65 years and older undergoing abdominal surgery, including both elective and emergency procedures. CPO is a hemodynamic parameter reflecting overall cardiac pumping power and may provide additional physiologic information beyond traditional risk models. P-POSSUM is widely used to estimate postoperative morbidity and mortality based on physiological and operative variables.
Eligible patients will be assessed in the preoperative period. Preoperative CPO will be obtained using non-invasive hemodynamic measurements as part of routine perioperative practice. The P-POSSUM score will be calculated for each patient using standard definitions. Patients will be followed during the postoperative period to document clinical outcomes, including postoperative complications and mortality within the predefined follow-up window, as well as length of hospital stay when available.
The primary objective is to assess the association between preoperative CPO and the P-POSSUM score. Secondary objectives include exploring whether preoperative CPO is associated with postoperative outcomes and whether it may help refine perioperative risk stratification. This study does not involve any investigational treatment; no additional interventions beyond standard clinical care will be performed. All data will be handled in accordance with applicable privacy and confidentiality regulations, and patient identifiers will not be included in the analysis dataset.
- Keywords
- p-possum score, cardiac power output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients aged 65 years and older undergoing abdominal surgery | This cohort consists of patients aged 65 years and older undergoing abdominal surgery, including both elective and emergency procedures. All participants will undergo preoperative evaluation, including non-invasive measurement of Cardiac Power Output (CPO) and calculation of the P-POSSUM score, as part of routine clinical assessment. No experimental intervention will be performed in this study, and all patients will receive standard clinical care and follow-up. Postoperative clinical outcomes will be recorded prospectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day postoperative mortality
All-cause mortality occurring within 30 days after abdominal surgery in patients aged 65 years and older (yes/no).
Measured: Up to 30 days after surgery
Secondary outcomes (2)
Postoperative morbidity
Postoperative morbidity assessed using the Postoperative Morbidity Survey (POMS).
Measured: Up to 30 days after surgery
Early postoperative morbidity
Early postoperative morbidity assessed using the Postoperative Morbidity Survey (POMS) on postoperative day 3.
Measured: Postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start10 Mar 2026
- Primary completionSep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Risk AssessmentStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan 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
- 120 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ŞULE ARICAN, Necmettin Erbakan University
- Investigators
- ŞULE ARICAN, Assoc. Prof., Principal investigator, Konya Necmettin Erbakan UniversityEngin Kılınç, Medical Doctor, Study director, Konya Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454564
- Sponsor's protocol ID
- 2025/5880
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Preoperative Cardiac Power Output and P-POSSUM Score
- ClinicalTrials.gov ID
- NCT07454564
- Acronym / sponsor ID
- 2025/5880
- Keywords
- p-possum score, cardiac power output
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 6 Mar 2026 (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.
This study aims to investigate the relationship between preoperative Cardiac Power Output (CPO), which reflects the pumping capacity of the heart, and the P-POSSUM score, a widely used surgical risk assessment tool, in patients aged 65 years and older undergoing abdominal surgery. Simple and non-invasive measurements performed in the preoperative period will be used to obtain CPO values and to evaluate whether these measurements are helpful in predicting postoperative morbidity and mortality. No additional procedures beyond routine clinical care will be performed as part of this observational study. The findings of this study may contribute to a more accurate assessment of surgical risk and help improve patient safety in the perioperative period.
Detailed description
This is a prospective, observational study designed to evaluate the relationship between preoperative Cardiac Power Output (CPO) and the P-POSSUM risk score in patients aged 65 years and older undergoing abdominal surgery, including both elective and emergency procedures. CPO is a hemodynamic parameter reflecting overall cardiac pumping power and may provide additional physiologic information beyond traditional risk models. P-POSSUM is widely used to estimate postoperative morbidity and mortality based on physiological and operative variables.
Eligible patients will be assessed in the preoperative period. Preoperative CPO will be obtained using non-invasive hemodynamic measurements as part of routine perioperative practice. The P-POSSUM score will be calculated for each patient using standard definitions. Patients will be followed during the postoperative period to document clinical outcomes, including postoperative complications and mortality within the predefined follow-up window, as well as length of hospital stay when available.
The primary objective is to assess the association between preoperative CPO and the P-POSSUM score. Secondary objectives include exploring whether preoperative CPO is associated with postoperative outcomes and whether it may help refine perioperative risk stratification. This study does not involve any investigational treatment; no additional interventions beyond standard clinical care will be performed. All data will be handled in accordance with applicable privacy and confidentiality regulations, and patient identifiers will not be included in the analysis dataset.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients aged 65 years and older undergoing abdominal surgery | – | –This cohort consists of patients aged 65 years and older undergoing abdominal surgery, including both elective and emergency procedures. All participants will undergo preoperative evaluation, including non-invasive measurement of Cardiac Power Output (CPO) and calculation of the P-POSSUM score, as part of routine clinical assessment. No experimental intervention will be performed in this study, and all patients will receive standard clinical care and follow-up. Postoperative clinical outcomes will be recorded prospectively. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This study will include patients aged 65 and over who are scheduled for abdominal surgery at Necmettin Erbakan University Faculty of Medicine Hospital.
Key inclusion criteria (9 listed)
- Undergoing abdominal surgery in general surgery practice (including elective and emergency procedures),
- ASA (American Society of Anesthesiologists) class I-III,
- Adequate recording with transthoracic echocardiography,
- Having given informed consent.
- Exclusion Criteria:Advanced heart failure with ejection fraction (EF) <30%,
Key exclusion criteria (0 listed)
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
30-day postoperative mortality
Time frame: Up to 30 days after surgery
All-cause mortality occurring within 30 days after abdominal surgery in patients aged 65 years and older (yes/no).
2 secondary outcomes
Postoperative morbidity
Time frame: Up to 30 days after surgery
Early postoperative morbidity
Time frame: Postoperative day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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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.
ŞULE ARICAN, Assoc. Prof. principal investigator
Konya Necmettin Erbakan University
Engin Kılınç, Medical Doctor study director
Konya Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Risk Assessment and Postoperative Mortality, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
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 9 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Engin Kılınç, Medical Doctor (00 90 332 223 60 00, enginkilinc96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day postoperative mortality (time frame: Up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2026.