- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07287280
Comparing CCI and POSSUM for Predicting Oncogynecologic Surgery Complications
A Comparison of the Charlson Comorbidity Index (CCI) vs POSSUM Score for Prediction of Perioperative Complications in Patients Undergoing Oncogynecologic Surgery
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Patchareya Nivatpumin, M.D.
- Phone Number: +66896662187
- Email: patchareya.niv@mahidol.ac.th
Study Contact Backup
- Name: Jitsupa Nithiuthai, M.D.
- Phone Number: +66654536516
- Email: jitsupa.nithiuthai@gmail.com
Study Locations
-
-
-
Bangkok, Thailand, 10700
- Recruiting
- Faculty of Medicine Siriraj Hospital, Mahidol University
-
Contact:
- Patcharyea Nivatpumin, M.D.
- Phone Number: +66896662187
- Email: patchareya.niv@mahidol.ac.th
-
Contact:
- Jitsupa Nithiuthai, M.D.
- Phone Number: +654536516
- Email: jitsupa.nithiuthai@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 years
- Patient underwent elective onco-gynecologic surgery
Exclusion Criteria:
- Patient required emergency surgery from any indication
- Patient chart that not contained primary outcome data eg. absent of the anesthetic record
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
from the date of starting surgery to the date of hospital discharge, up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative hypotension
Time Frame: Within 24 hours from starting of surgery
|
Intraoperative complications related to anesthesia: intraoperative hypotension
|
Within 24 hours from starting of surgery
|
|
Quantity of intraoperative blood loss
Time Frame: Within 24 hours from starting of surgery
|
Intraoperative blood loss estimated by anesthetic personnel
|
Within 24 hours from starting of surgery
|
|
Rate of blood transfusion
Time Frame: Within 24 hours from starting of surgery
|
Intraoperative rate and amount of packed red cells blood transfusion and/or blood component
|
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
|
Intraoperative rate and amount of vasopressor usage
|
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
|
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
|
from the date of starting surgery to the date of hospital discharge, up to 30 days
|
|
ICU admission
Time Frame: within 24 hours postoperative
|
Rate of intensive care unit admission in the postoperative period
|
within 24 hours postoperative
|
|
Reoperation
Time Frame: within 24 hours postoperative
|
Rate of reoperation
|
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
|
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)
|
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
|
Rate of acute kidney injury which defined follow the KDIGO clinical practice guidelines for acute kidney injury 2020
|
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
|
Rate of postoperative pulmonary complications which defined follow the European Perioperative clinical outcome (EPCO) definition for postoperative pulmonary complications
|
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
|
30-day mortality
|
From the day of surgery to 30 days post operation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patchareya Nivatpumin, M.D., Department Of Anesthesiology, Faculty Of Medicine Siriraj Hospital
Study record dates
Study Major Dates
Study Start (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 339/2568(IRB4)
- Si 428/2025 (Other Identifier: Ethical committee, Faculty of Medicine Sirirak Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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 Care
-
Karolinska InstitutetCompleted
-
Cardiff UniversityCardiff and Vale University Health BoardCompletedPerioperative CareUnited Kingdom
-
Medical University of SilesiaCompletedPerioperative CarePoland
-
Jordan LeitchCompleted
-
Haukeland University HospitalCompleted
-
Aydin Adnan Menderes UniversityCompletedPerioperative Care | Nursing Care | Privacy StatementsTurkey
-
University of Wisconsin, MadisonCompletedPerioperative Care | ReadmissionUnited States
-
Peking University First HospitalRecruitingProtocol-based Management and Perioperative Outcomes in Patients With Chronic Antithrombotic TherapyPerioperative Care | Antithrombotic Therapy | Perioperative OutcomesChina
-
Universidad de ZaragozaUniversidad Miguel Hernandez de ElcheNot yet recruitingPerioperative Care | Enhanced Recovery After Surgery | Surgical CareSpain
-
Kyoto UniversityRecruitingPerioperative Care | Antiplatelet AgentsJapan
Clinical Trials on CCI score
-
Children's Hospital of PhiladelphiaCompleted
-
University of RochesterNational Institute on Aging (NIA)CompletedMild Cognitive ImpairmentUnited States
-
PharmaMatrix Holdings LtdUniversity of AlbertaRecruitingCancer: Recurrent and/or Metastatic Solid TumoursCanada
-
University of HawaiiCompleted
-
TiGenix n.v.CompletedArticular Cartilage Lesion of the Femoral CondyleBelgium, Croatia, Germany, Netherlands
-
Soba University HospitalTerminatedAcute AppendicitisNigeria, Mexico, Spain, India, Pakistan, Sudan
-
Ain Shams UniversityRecruiting
-
Sohag UniversityNot yet recruiting
-
Nanjing PLA General HospitalCompletedCritical Illness | Gastrointestinal Dysfunction | Intestine Ultrasonography
-
Uludag UniversityRecruitingBrain Injuries, TraumaticTurkey