Predicting Morbidity and Mortality in Elderly Surgical Patients

NCT ID: NCT05216107

Last Updated: 2022-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-09-01

Brief Summary

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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

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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.

Conditions

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Surgery--Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hospital Universitario de Álava, Spain

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.

No interventions assigned to this group

Hospital Universitario de Basurto, Spain

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.

No interventions assigned to this group

Hospital Universitario de Cruces, Spain

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.

No interventions assigned to this group

Hospital Universitario de Donostia, Spain

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.

No interventions assigned to this group

Hospital San Pedro (Logroño), Spain

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.

No interventions assigned to this group

Hospital of Navarra, Spain

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitario Alava

UNKNOWN

Sponsor Role collaborator

Hospital de Cruces

OTHER

Sponsor Role collaborator

Hospital de Basurto

OTHER

Sponsor Role collaborator

Hospital Donostia

OTHER

Sponsor Role collaborator

Hospital San Pedro de Logroño

OTHER

Sponsor Role collaborator

Hospital of Navarra

OTHER

Sponsor Role lead

Responsible Party

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Ines Eguaras

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UPNA

Pamplona, Navarre, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Inés Córdoba, MD

Role: CONTACT

666909487

Facility Contacts

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Ines Eguaras, Resident

Role: primary

666909487

Other Identifiers

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Hospital Universitario Navarra

Identifier Type: -

Identifier Source: org_study_id

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