Predicting Morbidity and Mortality in Elderly Surgical Patients

Surgery--Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05216107
• Other study ID #: Hospital Universitario Navarra
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: January 2022
• Source: Hospital of Navarra
• Contact: Inés Córdoba, MD
• Phone: 666909487
• Email: ineseguaras[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: September 1, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgery--Complications

Locations

Country	Name	City	State
Spain	UPNA	Pamplona	Navarra

Sponsors (6)

Lead Sponsor	Collaborator
Hospital of Navarra	Hospital de Basurto, Hospital San Pedro, Hospital Universitario Alava, Hospital Universitario Cruces, Hospital Universitario Donostia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of postoperative mortality	prediction of the individual tools as ascertained from the official mortality records	30 day
Primary	Number of postoperative mortality	prediction of the individual tools as ascertained from the official mortality records	90 day
Primary	In-hospital surgery-related adverse events	Defined by the Clavien-Dindo classification	30 day
Secondary	validity of the score	Discrimination and calibration of the new tool, compared to the: m CRISTAL, USEM, NELA	30-day
Secondary	validity of the score	Discrimination and calibration of the new tool, compared to the: m CRISTAL, USEM, NELA	90-day