Frail Elderly SyndromeNCT05594277
Frailty and Surgery
An observational study of Frail Elderly Syndrome, run by Università degli Studi del Piemonte Orientale Amedeo Avogadro at 1 site in Italy.
Trial summary
Frailty has been recently re-defined as a condition that is evident over time through an excess of vulnerability to stressors, with reduced ability to maintain or regain homeostasis after a destabilizing event, and occurrence of disability. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frail Elderly Syndrome
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2020to 31 Oct 2023
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients affering to Maggiore della Carità University Hospital and Local Health Authority of Novara, Italy, listed for major surgery in general and vascular surgery, urology, orthopedics
Who may be able to join
- ≥ 70 years old
- Listed for major surgery in general and vascular surgery, urology, orthopedics
- Patient General Practitioner listed in the Local Health Authority of Novara
Who cannot join
- Barthel index at baseline < 16 in the activities of daily living section
- Barthel index at baseline < 11 in the mobility section
- Mini mental state examination at baseline < 11
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Hospitalization After Major Surgery on Elderly Frail Patients: a Prospective Observational Study
Frailty has been recently re-defined as a condition that is evident over time through an excess of vulnerability to stressors, with reduced ability to maintain or regain homeostasis after a destabilizing event, and occurrence of disability. Frailty has been often used to characterize the weakest and most vulnerable subset of older adults, because of age, comorbidities, social and emotional status leading to the lack of functional and psychological reserve and mining the capability to face acute events. Frail patients are becoming ever more present in Anesthesia and Intensive Care. In fact, 30 percent of surgery is conducted on patients ≥ 70 years old nowadays. It has been demonstrated that the impact of surgery and anesthesiologic risk are greater in older frail subjects, and that a low functional status is associated with increased mortality. Also, post-operative delirium and cognitive disfunction are more often seen in older patients. For this reason, the worsening of the global performance status, as functional status, mobility, and cognitive status may have a large impact on patient and caregivers' life. The primary objective is to evaluate the impact at three months after hospitalization following major surgery i.e., urology, general surgery, orthopedics, on the performance status as functional status, mobility, and cognitive status of patients ≥ 70 years old. Secondary objectives are to evaluate the necessity of domiciliary care assistance and re-hospitalization or rehabilitation center admissions in three months following surgery and to evaluate the impact of the type of anesthesia used in major surgery i.e., general vs regional anesthesia, on patient performance status.
- Conditions
- Frail Elderly Syndrome
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 |
|---|---|---|
| surgical elderly patients | Patients ≥ 70 years old, undergoing a major surgery in general and vascular surgery, urology, orthopedics at Maggiore della Carità University Hospital, Novara, Italy, having a General Practitioner listed in the Local Health Authority of Novara. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worsening of the performance status as functional status, mobility, and cognitive status after hospitalization for major surgery
Ten-point worsening of Barthel index globally, in the activities of daily living section and in the mobility section, and worsening of the mini mental state examination three months after surgery
Measured: Three months
Secondary outcomes (3)
Necessity of domiciliary care assistance
Necessity of domiciliary care assistance activation following hospital discharge after major surgery
Measured: Three months
Re-hospitalization or rehabilitation center admissions
Necessity of re-hospitalization or rehabilitation center admissions in the three months after major surgery
Measured: Three months
Impact of the type of anesthesia used in major surgery, general vs regional anesthesia, on patient performance status
Ten-point worsening of Barthel index globally, in the activities of daily living section and in the mobility section, and worsening of the mini mental state examination three months after surgery based on the type of anesthesia used in major surgery
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 May 2020
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Moretto, Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Investigators
- Rosanna Vaschetto, Professor, Study chair, Università degli Studi del Piemonte Orientale Amedeo Avogadro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594277
- Sponsor's protocol ID
- 421/CE
- Status last verified
- Mar 2024
- First submitted
- 21 Oct 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moretto F, Fracazzini M, Scotti L, Viarengo V, Gentilli S, Romito R, Volpe A, Leigheb M, Porta CM, Konrad P, Colombo D, Olivieri C, Della Corte F, Cammarota G, Vaschetto R. Major Elective Surgery Impact on Performance Status in Older Adults: A Prospective Observational Study. Health Sci Rep. 2025 Nov 2;8(11):e71438. doi: 10.1002/hsr2.71438. eCollection 2025 Nov.
PubMed 41189953
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Hospitalization After Major Surgery on Elderly Frail Patients: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05594277
- Acronym / sponsor ID
- 421/CE
- Conditions
- Frail Elderly Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Università degli Studi del Piemonte Orientale Amedeo AvogadroUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 26 Oct 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.
Frailty has been recently re-defined as a condition that is evident over time through an excess of vulnerability to stressors, with reduced ability to maintain or regain homeostasis after a destabilizing event, and occurrence of disability. Frailty has been often used to characterize the weakest and most vulnerable subset of older adults, because of age, comorbidities, social and emotional status leading to the lack of functional and psychological reserve and mining the capability to face acute events. Frail patients are becoming ever more present in Anesthesia and Intensive Care. In fact, 30 percent of surgery is conducted on patients ≥ 70 years old nowadays. It has been demonstrated that the impact of surgery and anesthesiologic risk are greater in older frail subjects, and that a low functional status is associated with increased mortality. Also, post-operative delirium and cognitive disfunction are more often seen in older patients. For this reason, the worsening of the global performance status, as functional status, mobility, and cognitive status may have a large impact on patient and caregivers' life. The primary objective is to evaluate the impact at three months after hospitalization following major surgery i.e., urology, general surgery, orthopedics, on the performance status as functional status, mobility, and cognitive status of patients ≥ 70 years old. Secondary objectives are to evaluate the necessity of domiciliary care assistance and re-hospitalization or rehabilitation center admissions in three months following surgery and to evaluate the impact of the type of anesthesia used in major surgery i.e., general vs regional anesthesia, on patient performance status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgical elderly patients | – | –Patients ≥ 70 years old, undergoing a major surgery in general and vascular surgery, urology, orthopedics at Maggiore della Carità University Hospital, Novara, Italy, having a General Practitioner listed in the Local Health Authority of Novara. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients affering to Maggiore della Carità University Hospital and Local Health Authority of Novara, Italy, listed for major surgery in general and vascular surgery, urology, orthopedics
Key inclusion criteria (3 listed)
- ≥ 70 years old
- Listed for major surgery in general and vascular surgery, urology, orthopedics
- Patient General Practitioner listed in the Local Health Authority of Novara
Key exclusion criteria (3 listed)
- Barthel index at baseline < 16 in the activities of daily living section
- Barthel index at baseline < 11 in the mobility section
- Mini mental state examination at baseline < 11
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
Worsening of the performance status as functional status, mobility, and cognitive status after hospitalization for major surgery
Time frame: Three months
Ten-point worsening of Barthel index globally, in the activities of daily living section and in the mobility section, and worsening of the mini mental state examination three months after surgery
3 secondary outcomes
Necessity of domiciliary care assistance
Time frame: Three months
Re-hospitalization or rehabilitation center admissions
Time frame: Three months
Impact of the type of anesthesia used in major surgery, general vs regional anesthesia, on patient performance status
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 41189953Moretto F, Fracazzini M, Scotti L, Viarengo V, Gentilli S, Romito R, Volpe A, Leigheb M, Porta CM, Konrad P, Colombo D, Olivieri C, Della Corte F, Cammarota G, Vaschetto R. Major Elective Surgery Impact on Performance Status in Older Adults: A Prospective Observational Study. Health Sci Rep. 2025 Nov 2;8(11):e71438. doi: 10.1002/hsr2.71438. eCollection 2025 Nov.
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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.
Rosanna Vaschetto, Professor study chair
Università degli Studi del Piemonte Orientale Amedeo Avogadro
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 Frail Elderly Syndrome, run by Università degli Studi del Piemonte Orientale Amedeo Avogadro at 1 site in Italy.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 6 Mar 2024. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worsening of the performance status as functional status, mobility, and cognitive status after hospitalization for major surgery (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05594277, which also lists 1 linked publication.
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 6 Mar 2024.