Predicting Morbidity and Mortality in Elderly Surgical Patients

NCT05216107 | Unknown DMC

• 1 other identifier: Hospital Universitario Navarra
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery--Complications

Keywords

Elderly; urgent abdominal surgery; 30-day mortality

Outcome Measures

Primary Outcomes (3)

• Number of postoperative mortality

  prediction of the individual tools as ascertained from the official mortality records

  30 day

• Number of postoperative mortality

  prediction of the individual tools as ascertained from the official mortality records

  90 day

• In-hospital surgery-related adverse events

  Defined by the Clavien-Dindo classification

  30 day

Secondary Outcomes (2)

• validity of the score

  30-day

• validity of the score

  90-day

Study Arms (6)

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.

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.

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.

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.

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.

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.

Eligibility Criteria

• Age: 65 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital of Navarra: lead
• Hospital Universitario Alava: collaborator
• Hospital de Cruces: collaborator
• Hospital de Basurto: collaborator
• Hospital Donostia: collaborator
• Hospital San Pedro de Logroño: collaborator

Study Sites (1)

UPNA

Pamplona, Navarre, 31008, Spain

RECRUITING

Central Study Contacts

Inés Córdoba, MD

CONTACT

666909487; ineseguaras@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 31, 2022
• Study Start: January 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: September 1, 2023
• Last Updated: February 15, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)