Surgery--ComplicationsNCT05216107
Predicting Morbidity and Mortality in Elderly Surgical Patients
An observational study of Surgery--Complications, run by Hospital of Navarra at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 65 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery--Complications
- How many people
- 1,800 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 1 Sep 2023
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 105 years
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- Patients aged ≥65 years.
- Present in the ED with acute abdominal pathology that requires urgent abdominal surgery
Who cannot join
- Patients who receive non-operative management
- Informed consent form not signed by patient or their proxy
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
UPNA
Pamplona, Navarre, 31008
Ines Eguaras, Resident, 666909487, ineseguaras@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgery--Complications
- Keywords
- Elderly, urgent abdominal surgery, 30-day mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of postoperative mortality
prediction of the individual tools as ascertained from the official mortality records
Measured: 30 day
Number of postoperative mortality
prediction of the individual tools as ascertained from the official mortality records
Measured: 90 day
In-hospital surgery-related adverse events
Defined by the Clavien-Dindo classification
Measured: 30 day
Secondary outcomes (2)
validity of the score
Discrimination and calibration of the new tool, compared to the: m CRISTAL, USEM, NELA
Measured: 30-day
validity of the score
Discrimination and calibration of the new tool, compared to the: m CRISTAL, USEM, NELA
Measured: 90-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Jan 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Hospital of Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Alava, Hospital de Cruces, Hospital de Basurto, Hospital Donostia, Hospital San Pedro de Logroño
- Responsible party
- Principal investigator, Ines Eguaras, Hospital of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216107
- Sponsor's protocol ID
- Hospital Universitario Navarra
- Status last verified
- Jan 2022
- First submitted
- 27 Dec 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Morbidity and Mortality in Elderly Surgical Patients: Prospective Multicentre Study
- ClinicalTrials.gov ID
- NCT05216107
- Acronym / sponsor ID
- Hospital Universitario Navarra
- Conditions
- Surgery--Complications
- Keywords
- Elderly, urgent abdominal surgery, 30-day mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Hospital of NavarraUniversity, hospital or other
- Collaborators
- Hospital Universitario Alava, Hospital de Cruces, Hospital de Basurto, Hospital Donostia, Hospital San Pedro de Logroño
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients aged ≥65 years.
- Present in the ED with acute abdominal pathology that requires urgent abdominal surgery
Key exclusion criteria (2 listed)
- Patients who receive non-operative management
- Informed consent form not signed by patient or their proxy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of postoperative mortality
Time frame: 30 day
prediction of the individual tools as ascertained from the official mortality records
Number of postoperative mortality
Time frame: 90 day
prediction of the individual tools as ascertained from the official mortality records
In-hospital surgery-related adverse events
Time frame: 30 day
Defined by the Clavien-Dindo classification
2 secondary outcomes
validity of the score
Time frame: 30-day
validity of the score
Time frame: 90-day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery--Complications, run by Hospital of Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inés Córdoba, MD (666909487, ineseguaras@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of postoperative mortality (time frame: 30 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.