Gynecologic Surgical ProceduresNCT07287280
Comparing CCI and POSSUM for Predicting Oncogynecologic Surgery Complications
An observational study of Gynecologic Surgical Procedures and Risk Assessment, run by Mahidol University at 1 site in Thailand.
Trial summary
With the global rates of gynecologic cancers on the rise, optimizing perioperative care is imperative. Accurate risk prediction is essential for enhancing patient care, directing preoperative interventions, and facilitating informed decision-making in oncology. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Surgical Procedures, Risk Assessment, Perioperative Care
- What is being tested?
- CCI score and POSSUM score
- How many people
- 300 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2025to 31 Oct 2027
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patient aged >,= 18 years, underwent elective onco-gynecologic surgery.
Who may be able to join
- Age > 18 years
- Patient underwent elective onco-gynecologic surgery
Who cannot join
- Patient required emergency surgery from any indication
- Patient chart that not contained primary outcome data eg. absent of the anesthetic record
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
Patcharyea Nivatpumin, M.D., +66896662187, patchareya.niv@mahidol.ac.th
Jitsupa Nithiuthai, M.D., +654536516, jitsupa.nithiuthai@gmail.com
About this study
Official title: A Comparison of the Charlson Comorbidity Index (CCI) vs POSSUM Score for Prediction of Perioperative Complications in Patients Undergoing Oncogynecologic Surgery
With the global rates of gynecologic cancers on the rise, optimizing perioperative care is imperative. Accurate risk prediction is essential for enhancing patient care, directing preoperative interventions, and facilitating informed decision-making in oncology. This research compares two widely-used risk assessment tools: the Charlson Comorbidity Index (CCI) and the Physiological and Operative Severity Score for the enUmeration of Mortality and Morbidity (POSSUM), in predicting perioperative outcomes. The CCI predominantly addresses comorbidities, providing simplicity and broad applicability, while POSSUM incorporates both physiological and operative factors for a more comprehensive risk assessment. Despite their application across various surgical specialties, the specific utility of these tools in onco-gynecologic surgery remains insufficiently explored. The study aims to evaluate the effectiveness of CCI and POSSUM in predicting perioperative complications, with a focus on the incidence of these complications, length of hospital stay, and 30-day mortality. The implementation of these risk tools may enhance multidisciplinary risk management, thus improving patient outcomes in gynecologic oncology surgery.
Read the detailed description
Onco-gynecologic surgeries, including procedures for ovarian, cervical, uterine, and vulvar cancers, are complex and challenging due to both the technical intricacies of the surgeries and the often compromised health of cancer patients. These procedures carry significant perioperative risks, making optimization of perioperative care critical, especially as global cases of gynecological cancers rise, with millions affected annually. Accurate risk prediction is vital to improve patient outcomes, allowing surgeons and anesthesiologists to tailor preoperative interventions and intraoperative management. These strategies help in identifying high-risk patients, implementing enhanced monitoring, specific anesthetic techniques, or staged surgical approaches to mitigate potential complications.
Two prominent risk assessment tools used in surgical practice are the Charlson Comorbidity Index (CCI) and the Physiological and Operative Severity Score for the enUmeration of Mortality and Morbidity (POSSUM). The CCI, is a weighted index that considers the number and severity of comorbid conditions to predict mortality risk. Its simplicity and reliance on readily available clinical information have led to its widespread adoption in clinical and research settings. Studies have validated its predictive value across various surgical populations, including oncology patients, although its specific utility in onco-gynecologic surgeries needs further exploration.
In contrast, the POSSUM score offers a more comprehensive risk assessment by incorporating both physiological and operative factors. It includes preoperative variables like age and cardiac signs and considers operative factors like procedural complexity and blood loss. This dual approach provides a nuanced prediction of perioperative risk, useful across diverse surgical fields. Despite POSSUM's broad application, its effectiveness specifically in onco-gynecologic surgeries requires additional investigation to fully ascertain its predictive accuracy and utility.
Currently, our center conducts preoperative evaluations involving anesthesiologists and gynecologists, yet formal risk assessments using CCI or POSSUM have not been implemented. Incorporating these tools could enhance multidisciplinary risk management, involving anesthetic teams, ward nurses, gynecologic oncologists, and intensivists. By systematically evaluating patient history, these indices can promote effective interdisciplinary communication, significantly improve patient safety, and optimize surgical outcomes.
This study aims to compare CCI and POSSUM in predicting perioperative complications, including both anesthetic and surgical complications in onco-gynecologic surgery. Additionally, it seeks to report the incidence of complications, length of hospital stay, and 30-day mortality, providing valuable insights into optimizing patient care in this challenging field.
- Being tested
- CCI score, POSSUM score
- Keywords
- Gynecologic oncology surgery, Perioperative complications, Charlson comorbidity index, POSSUM, Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCI scoreOther
Also called Charlson comorbidity index
Charlson comorbidity index included age and medical conditions
POSSUM scoreOther
Also called Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity
POSSUM included physical status and laboratory investigation
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of CCI and POSSUM to predict perioperative complications
To compare the prediction of perioperative anesthetic and surgical morbidity by the Charlson-Comorbidity Index versus POSSUM score in patients undergoing elective onco-gynecological surgery
Measured: from the date of starting surgery to the date of hospital discharge, up to 30 days
Secondary outcomes (11)
Intraoperative hypotension
Intraoperative complications related to anesthesia: intraoperative hypotension
Measured: Within 24 hours from starting of surgery
Quantity of intraoperative blood loss
Intraoperative blood loss estimated by anesthetic personnel
Measured: Within 24 hours from starting of surgery
Rate of blood transfusion
Intraoperative rate and amount of packed red cells blood transfusion and/or blood component
Measured: Within 24 hours from starting of surgery
Rate of vasopressor usage
Intraoperative rate and amount of vasopressor usage
Measured: from the time staring of surgery to the time of finishing surgery, up to 12 hours
Clavian-Dindo classification of surgical complications
Rate of surgical complications using Clavian-Dindo classification of surgical complications Grade 1 Treatment with simple medication Grade 2 Others medications from grade 1 Grade 3a Surgical intervention under local/regional anesthesia Grade 3b Surgical intervention under general anesthesia Grade 4a Need ICU with single organ dysfunction Grade 4b Need ICU with multiple organ dysfunction Grade 5 Death
Measured: from the date of starting surgery to the date of hospital discharge, up to 30 days
ICU admission
Rate of intensive care unit admission in the postoperative period
Measured: within 24 hours postoperative
Reoperation
Rate of reoperation
Measured: within 24 hours postoperative
Myocardial infarction or myocardial injury
Rate of postoperative myocardial infarction and myocardial injury after non-cardiac surgery (MINS)defines as an >1 fold-elevated cTn (>99th percentile of the upper reference limit) of presumed ischemic origin (excluding nonischemic etiologies such as pulmonary embolism, stroke, and sepsis) and is associated with adverse short- and long-term outcomes. (from the 2024 AHA/ACC/ACS/ASNC/HRS/SCA/ SCCT/SCMR/SVM Guideline for Perioperative Cardiovascular Management for Noncardiac Surgery: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines)
Measured: from the date of starting surgery to the date of hospital discharge, up to 30 days
Acute kidney injury
Rate of acute kidney injury which defined follow the KDIGO clinical practice guidelines for acute kidney injury 2020
Measured: from the date of starting surgery to the date of hospital discharge, up to 30 days
Postoperative pulmonary complications
Rate of postoperative pulmonary complications which defined follow the European Perioperative clinical outcome (EPCO) definition for postoperative pulmonary complications
Measured: from surgery from the date of starting surgery to the date of hospital discharge, up to 30 days
Mortality rate
30-day mortality
Measured: From the day of surgery to 30 days post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Sep 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic Surgical ProceduresStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patchareya Nivatpumin, M.D., Principal investigator, Department of Anesthesiology, Faculty of Medicine Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287280
- Sponsor's protocol ID
- 339/2568(IRB4)
- Other IDs
- Si 428/2025
- Status last verified
- Dec 2025
- First submitted
- 23 Jun 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data supporting the findings of this study are available upon reasonable request, subject to approval and permission from the hospital's director.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Charlson Comorbidity Index (CCI) vs POSSUM Score for Prediction of Perioperative Complications in Patients Undergoing Oncogynecologic Surgery
- ClinicalTrials.gov ID
- NCT07287280
- Acronym / sponsor ID
- 339/2568(IRB4)
- Keywords
- Gynecologic oncology surgery, Perioperative complications, Charlson comorbidity index, POSSUM, Mortality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 17 Dec 2025 (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.
With the global rates of gynecologic cancers on the rise, optimizing perioperative care is imperative. Accurate risk prediction is essential for enhancing patient care, directing preoperative interventions, and facilitating informed decision-making in oncology. This research compares two widely-used risk assessment tools: the Charlson Comorbidity Index (CCI) and the Physiological and Operative Severity Score for the enUmeration of Mortality and Morbidity (POSSUM), in predicting perioperative outcomes. The CCI predominantly addresses comorbidities, providing simplicity and broad applicability, while POSSUM incorporates both physiological and operative factors for a more comprehensive risk assessment. Despite their application across various surgical specialties, the specific utility of these tools in onco-gynecologic surgery remains insufficiently explored. The study aims to evaluate the effectiveness of CCI and POSSUM in predicting perioperative complications, with a focus on the incidence of these complications, length of hospital stay, and 30-day mortality. The implementation of these risk tools may enhance multidisciplinary risk management, thus improving patient outcomes in gynecologic oncology surgery.
Detailed description
Onco-gynecologic surgeries, including procedures for ovarian, cervical, uterine, and vulvar cancers, are complex and challenging due to both the technical intricacies of the surgeries and the often compromised health of cancer patients. These procedures carry significant perioperative risks, making optimization of perioperative care critical, especially as global cases of gynecological cancers rise, with millions affected annually. Accurate risk prediction is vital to improve patient outcomes, allowing surgeons and anesthesiologists to tailor preoperative interventions and intraoperative management. These strategies help in identifying high-risk patients, implementing enhanced monitoring, specific anesthetic techniques, or staged surgical approaches to mitigate potential complications.
Two prominent risk assessment tools used in surgical practice are the Charlson Comorbidity Index (CCI) and the Physiological and Operative Severity Score for the enUmeration of Mortality and Morbidity (POSSUM). The CCI, is a weighted index that considers the number and severity of comorbid conditions to predict mortality risk. Its simplicity and reliance on readily available clinical information have led to its widespread adoption in clinical and research settings. Studies have validated its predictive value across various surgical populations, including oncology patients, although its specific utility in onco-gynecologic surgeries needs further exploration.
In contrast, the POSSUM score offers a more comprehensive risk assessment by incorporating both physiological and operative factors. It includes preoperative variables like age and cardiac signs and considers operative factors like procedural complexity and blood loss. This dual approach provides a nuanced prediction of perioperative risk, useful across diverse surgical fields. Despite POSSUM's broad application, its effectiveness specifically in onco-gynecologic surgeries requires additional investigation to fully ascertain its predictive accuracy and utility.
Currently, our center conducts preoperative evaluations involving anesthesiologists and gynecologists, yet formal risk assessments using CCI or POSSUM have not been implemented. Incorporating these tools could enhance multidisciplinary risk management, involving anesthetic teams, ward nurses, gynecologic oncologists, and intensivists. By systematically evaluating patient history, these indices can promote effective interdisciplinary communication, significantly improve patient safety, and optimize surgical outcomes.
This study aims to compare CCI and POSSUM in predicting perioperative complications, including both anesthetic and surgical complications in onco-gynecologic surgery. Additionally, it seeks to report the incidence of complications, length of hospital stay, and 30-day mortality, providing valuable insights into optimizing patient care in this challenging field.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient aged >,= 18 years, underwent elective onco-gynecologic surgery.
Key inclusion criteria (2 listed)
- Age > 18 years
- Patient underwent elective onco-gynecologic surgery
Key exclusion criteria (2 listed)
- Patient required emergency surgery from any indication
- Patient chart that not contained primary outcome data eg. absent of the anesthetic record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCI scoreAlso: Charlson comorbidity indexCharlson comorbidity index included age and medical conditions | Other | – |
| POSSUM scoreAlso: Physiological and Operative Severity Score for the enUmeration of Mortality and morbidityPOSSUM included physical status and laboratory investigation | Other | – |
Primary outcome
Comparison of CCI and POSSUM to predict perioperative complications
Time frame: from the date of starting surgery to the date of hospital discharge, up to 30 days
To compare the prediction of perioperative anesthetic and surgical morbidity by the Charlson-Comorbidity Index versus POSSUM score in patients undergoing elective onco-gynecological surgery
11 secondary outcomes
Intraoperative hypotension
Time frame: Within 24 hours from starting of surgery
Quantity of intraoperative blood loss
Time frame: Within 24 hours from starting of surgery
Rate of blood transfusion
Time frame: Within 24 hours from starting of surgery
Rate of vasopressor usage
Time frame: from the time staring of surgery to the time of finishing surgery, up to 12 hours
Clavian-Dindo classification of surgical complications
Time frame: from the date of starting surgery to the date of hospital discharge, up to 30 days
ICU admission
Time frame: within 24 hours postoperative
Reoperation
Time frame: within 24 hours postoperative
Myocardial infarction or myocardial injury
Time frame: from the date of starting surgery to the date of hospital discharge, up to 30 days
Acute kidney injury
Time frame: from the date of starting surgery to the date of hospital discharge, up to 30 days
Postoperative pulmonary complications
Time frame: from surgery from the date of starting surgery to the date of hospital discharge, up to 30 days
Mortality rate
Time frame: From the day of surgery to 30 days post operation
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 17 Dec 2025.
- Individual participant dataSharing planned: Undecided. Data supporting the findings of this study are available upon reasonable request, subject to approval and permission from the hospital's director.
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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.
Patchareya Nivatpumin, M.D. principal investigator
Department of Anesthesiology, Faculty of Medicine Siriraj Hospital
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 Gynecologic Surgical Procedures and Risk Assessment, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 2 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 17 Dec 2025. 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 Thailand. 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 Patchareya Nivatpumin, M.D. (+66896662187, patchareya.niv@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of CCI and POSSUM to predict perioperative complications (time frame: from the date of starting surgery to the date of hospital discharge, up to 30 days). 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 17 Dec 2025.