Predicting Morbidity and Mortality in Elderly Surgical Patients

Predicting Morbidity and Mortality in Elderly Surgical Patients: Prospective Multicentre Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05216107

Enrollment

1800

Registered

2022-01-31

Start date

2022-01-01

Completion date

2023-09-01

Last updated

2022-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery--Complications

Keywords

Elderly, urgent abdominal surgery, 30-day mortality

Brief summary

This proposed multicentre study builds on the findings of our recent validation of USEM and mCriSTAl predictive tools in a single centre at the Complejo Hospitalario de Navarra, whose results were recently published (https://europepmc.org/article/med/33111261). By expanding to a multicentre cohort and comparing to a third instrument, the investigators aim to examine the independent validity and generalizability of three scores and investigate potential for simplification of the prediction with anticipated greater accuracy. The ultimate goal is to determine whether these predictive tool can be used to assist surgical decision-making about older patients with expected poorer prognosis or high risk of death in the short term.

Detailed description

Eligible institutions: large hospitals (\>200 beds) with wards admitting older surgical patients where (a) electronic medical records are available, (b) have staff committed to recruiting a minimum of 100 participants with complete follow-up, and (c) give consent for the Lead statistician in Spain to access de-identified data for aggregated analysis. Procedures: Recruitment is anticipated to take 6-12 months and will be conducted prospectively after screening by non-specialist hospital staff (junior doctors, medical students, nurses) confirms eligibility. The 3-month follow-up for outcomes will include completion of a standard questionnaire/form via either review of clinical record, access to death records (where applicable), or telephone call to families/proxy/next of kin/person responsible at 3 months after initial recruitment. Findings will be published in aggregated and anonymized form, but if the sample from individual participating institutions is large enough, hospital-specific profiles can be delivered in identifiable form to relevant hospitals for the benefit of clinicians and service administrators.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to 105 Years

Healthy volunteers

Yes

Inclusion criteria

* Patients aged ≥65 years. * Present in the ED with acute abdominal pathology that requires urgent abdominal surgery

Exclusion criteria

* Patients who receive non-operative management * Informed consent form not signed by patient or their proxy

Design outcomes

Primary

Measure	Time frame	Description
Number of postoperative mortality	30 day	prediction of the individual tools as ascertained from the official mortality records
In-hospital surgery-related adverse events	30 day	Defined by the Clavien-Dindo classification

Secondary

Measure	Time frame	Description
validity of the score	30-day	Discrimination and calibration of the new tool, compared to the: m CRISTAL, USEM, NELA

Countries

Spain

Contacts

Primary ContactInés Córdoba, MD

ineseguaras@hotmail.com666909487

Outcome results