NCT07667764

Brief Summary

Postoperative complications after abdominal surgery can lead to prolonged recovery, intensive care admission, and death. The P-POSSUM score is a commonly used surgical risk prediction tool, but its performance may vary between hospitals and patient populations. Frailty, especially in older patients, may also affect postoperative outcomes and may improve risk prediction when added to existing scoring systems. This ambispective observational cohort study evaluates the prognostic value of the P-POSSUM score, with additional assessment of frailty and routine perioperative clinical data, for predicting postoperative complications and treatment outcomes in adult patients undergoing abdominal surgery at Bach Mai Hospital. The study includes retrospective data from January 2025 and prospective data collection through May 2026. No intervention is assigned by the investigators. All patients receive routine perioperative care according to clinical practice. The study will assess the predictive performance of P-POSSUM for postoperative complications and mortality, and will explore whether adding frailty-related variables improves risk prediction.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 16, 2026

Last Update Submit

June 21, 2026

Conditions

Keywords

P-POSSUMModified Frailty IndexAbdominal surgeryClinical Frailty ScalePrognostic scorePerioperative risk assessment

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with postoperative complications within 30 days after abdominal surgery

    The proportion of patients who develop one or more postoperative complications after abdominal surgery. Postoperative complications include surgical, infectious, respiratory, cardiovascular, renal, neurological, bleeding-related, or other clinically documented complications requiring treatment, monitoring, ICU care, reoperation, or other medical intervention. Complications will be identified from anesthesia records, surgical records, ICU charts, laboratory and imaging results, discharge summaries, and hospital medical records. This outcome will be used to evaluate the prognostic performance of P-POSSUM and frailty-enhanced risk prediction.

    Within 30 days after surgery or until hospital discharge, whichever occurs first

Secondary Outcomes (5)

  • All-cause mortality within 30 days after abdominal surgery

    Within 30 days after surgery or until hospital discharge, whichever occurs first

  • Discrimination of P-POSSUM for postoperative complications

    Postoperative complications occurring from the end of surgery through 30 days after surgery or hospital discharge, whichever occurs first.

  • Incremental discrimination of frailty-related variables added to P-POSSUM

    Postoperative complications occurring from the end of surgery through 30 days after surgery or hospital discharge, whichever occurs first.

  • Intensive care unit length of stay

    From ICU admission until ICU discharge or death, assessed up to 30 days after ICU admission.

  • Hospital length of stay

    From hospital admission until hospital discharge or in-hospital death, assessed up to 90 days after hospital admission.

Study Arms (1)

Abdominal Surgery Cohort

Adult patients undergoing abdominal surgery at Bach Mai Hospital who meet the study eligibility criteria. Participants will be identified from retrospective records from January 2025 and prospectively collected data through May 2026. No intervention will be assigned by the investigators. P-POSSUM physiological and operative variables, frailty-related variables, routine perioperative clinical data, postoperative complications, and treatment outcomes will be collected to evaluate prognostic performance and risk prediction.

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Older adult patients aged 60 years or older undergoing abdominal surgery at Bach Mai Hospital. The study population includes patients identified from retrospective hospital records from January 2025 and prospectively collected data through May 2026. P-POSSUM variables, frailty-related variables, routine perioperative clinical data, postoperative complications, and treatment outcomes will be collected for prognostic evaluation.

You may qualify if:

  • Patients aged 60 years or older. Patients undergoing abdominal surgery at Bach Mai Hospital. Patients managed perioperatively or postoperatively by the Center for Anesthesia and Surgical Intensive Care.
  • Patients with available perioperative clinical data required to calculate the P-POSSUM score.
  • Patients with available baseline clinical, comorbidity, or functional status information for frailty assessment.
  • Patients with available postoperative outcome data for assessment of complications, mortality, or treatment outcomes.

You may not qualify if:

  • Patients younger than 60 years. Patients not undergoing abdominal surgery. Patients undergoing minor procedures without operative severity data required for P-POSSUM calculation.
  • Patients with missing key physiological or operative variables required to calculate the P-POSSUM score.
  • Patients with insufficient baseline information for frailty assessment. Patients with insufficient postoperative follow-up data for outcome assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bach Mai Hospital, Hanoi, Viet Nam.

Hanoi, Hanoi, 00000, Vietnam

Location

MeSH Terms

Conditions

Postoperative ComplicationsFrailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Director, Center for Anesthesia and Surgical Intensive Care

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 25, 2026

Study Start

January 1, 2026

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the main published results may be shared upon reasonable request. Shared data may include baseline demographic and clinical characteristics, P-POSSUM physiological and operative variables, frailty-related variables, routine perioperative data, postoperative complications, mortality, length of stay, and other treatment outcomes used in the final analysis. No directly identifiable participant information will be shared.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
De-identified individual participant data and supporting documents will be available after publication of the main study results. There is no predetermined end date for data availability; requests will be considered according to institutional policies, ethics requirements, and data sharing agreements.
Access Criteria
Data may be shared with qualified researchers for systematic reviews, meta-analyses, external validation, or scientifically valid secondary analyses. Access will require submission of a research proposal, approval by an ethics committee when applicable, and a signed data sharing agreement with the study custodian or sponsor. Requests should be sent to the study contact. Shared data will be de-identified and limited to variables necessary for the approved analysis.

Locations