NCT07287280

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Sep 2025Oct 2027

First Submitted

Initial submission to the registry

June 23, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

June 23, 2025

Last Update Submit

December 16, 2025

Conditions

Keywords

Gynecologic oncology surgeryPerioperative complicationsCharlson comorbidity indexPOSSUMMortality

Outcome Measures

Primary Outcomes (1)

  • 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

    from the date of starting surgery to the date of hospital discharge, up to 30 days

Secondary Outcomes (11)

  • Intraoperative hypotension

    Within 24 hours from starting of surgery

  • Quantity of intraoperative blood loss

    Within 24 hours from starting of surgery

  • Rate of blood transfusion

    Within 24 hours from starting of surgery

  • Rate 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

    from the date of starting surgery to the date of hospital discharge, up to 30 days

  • +6 more secondary outcomes

Interventions

Charlson comorbidity index included age and medical conditions

Also known as: Charlson comorbidity index

POSSUM included physical status and laboratory investigation

Also known as: Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient aged \>,= 18 years, underwent elective onco-gynecologic surgery.

You may qualify if:

  • Age \> 18 years
  • Patient underwent elective onco-gynecologic surgery

You may not qualify if:

  • Patient required emergency surgery from any indication
  • Patient chart that not contained primary outcome data eg. absent of the anesthetic record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Interventions

Morbidity

Intervention Hierarchy (Ancestors)

Vital StatisticsData CollectionEpidemiologic MethodsInvestigative TechniquesDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Patchareya Nivatpumin, M.D.

    Department of Anesthesiology, Faculty of Medicine Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patchareya Nivatpumin, M.D.

CONTACT

Jitsupa Nithiuthai, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2025

First Posted

December 17, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

December 17, 2025

Record last verified: 2025-12

Locations