Predicting Morbidity and Mortality in Elderly Surgical Patients

• Conditions: Surgery--Complications

• Registration Number: NCT05216107
• Lead Sponsor: Hospital of Navarra

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.

Study Timeline

• Study First Submitted: 2021-12-27
• Status Verified: 2022-01
• Study Start: 2022-01-01
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-31
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-15
• Primary Completion: 2022-12-30
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of postoperative mortality	90 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 Outcome Measures

Name	Time	Method
validity of the score	90-day	Discrimination and calibration of the new tool, compared to the: m CRISTAL, USEM, NELA

Trial Locations

Locations (1)

UPNA; 🇪🇸 Pamplona, Navarra, Spain