Clinical trial NCT05216107: Predicting Morbidity and Mortality in Elderly Surgical Patients
Official title: Predicting Morbidity and Mortality in Elderly Surgical Patients: Prospective Multicentre Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery--Complications
Keywords: Elderly
urgent abdominal surgery
30-day mortality
Lead sponsor: Hospital of Navarra
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Alava
name: Hospital de Cruces
name: Hospital de Basurto
name: Hospital Donostia
name: Hospital San Pedro de Logroño
First posted: 2022-01-31
Enrollment: 1800
Sex: ALL
Minimum age (years): 65
Maximum age (years): 105
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of postoperative mortality
timeFrame: 30 day
measure: Number of postoperative mortality
timeFrame: 90 day
measure: In-hospital surgery-related adverse events
timeFrame: 30 day
Secondary outcomes:
measure: validity of the score
timeFrame: 30-day
measure: validity of the score
timeFrame: 90-day
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: UPNA
state: Navarra
Study officials:
References: