Predicting Morbidity and Mortality in Elderly Surgical Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery--Complications

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.

• Study Type: Observational
• Enrollment (Anticipated): 1800

Contacts and Locations

• Study Contact: Name: Inés Córdoba, MD; Phone Number: 666909487; Email: ineseguaras@hotmail.com

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Recruiting
      • UPNA
      • Contact: Ines Eguaras, Resident; Phone Number: 666909487; Email: ineseguaras@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 105 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
validity of the score	Discrimination and calibration of the new tool, compared to the: m CRISTAL, USEM, NELA	30-day
validity of the score	Discrimination and calibration of the new tool, compared to the: m CRISTAL, USEM, NELA	90-day

Collaborators and Investigators

• Sponsor: Hospital of Navarra
• Collaborators: Hospital de Basurto; Hospital Universitario Donostia; Hospital Universitario Cruces; Hospital San Pedro; Hospital Universitario Alava

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Elderly; urgent abdominal surgery; 30-day mortality
• Other Study ID Numbers: Hospital Universitario Navarra

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No