SurgeryAPOPMNCT04770259
Pre-surgical Protocol for Frail Elderly People in Order to Reduce Hospitalization Days (APOPM).
A study testing Timely pre-surgical conditioning in people with Surgery and Old Age; Debility, run by Pontificia Universidad Catolica de Chile at 2 sites in Chile.
Trial summary
Elderly people (EP) have increased, as well as life expectancy at birth. In Chile there are more than 2 million 800 thousand EP, which corresponds to 1/6 of the Chilean population. The EP have a higher disease burden and mortality when facing surgery and in the postoperative period. Read more about this study
- Who is it for?
- Ages 65 to 105 years
- Conditions the study is for
- Surgery, Old Age; Debility, Frail Elderly Syndrome
- What is being tested?
- Timely pre-surgical conditioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 2 sitesChile
- Study dates
- 30 May 2021to 30 Nov 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- Elective surgery of urology and / or minimally invasive coloproctology under general anesthesia
- Pre-frail, frail patients.
- Patients with a moderate to severe degree of dependence
Who cannot join
- Emergency surgery patients.
- Patients who are hospitalized prior to surgery for urgent reasons and / or complications from another surgery.
- Patients diagnosed with delirum, dementia or similar mental illness.
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 450881
Hospital de La Florida
Santiago, Santiago Metropolitan, 8420525
About this study
Official title: Generation of a Pre-surgical Conditioning Protocol for Frail Elderly People in Order to Reduce Hospitalization Days.
Elderly people (EP) have increased, as well as life expectancy at birth. In Chile there are more than 2 million 800 thousand EP, which corresponds to 1/6 of the Chilean population.
The EP have a higher disease burden and mortality when facing surgery and in the postoperative period.
Read more
Thus, this population frequently has longer hospital stays due to its degree of fragility, surgical complications or decompensation of its underlying pathologies, directly affecting health care systems.
An inadequate preparation of the EP prior to surgery determined that the requirements of in-hospital as well as out-of-hospital care are extended, with the consequent which entails a higher cost in health.
Current research underestimates the conditions of frailty and dependence in the EP. In addition, it is not routinely evaluated prior to surgery, as well as nutritional, metabolic, cognitive status and / or delirium screening is performed.
There are accelerated recovery programs, which relate their interventions to specific pathologies; however, the age of the person is not taken into account.
Surgical pre-habilitation interventions in the EP usually focus their efforts on physical and cardiovascular aspects, not including an integrative pre-surgical evaluation.
Based on the foregoing, a prospective, interventional, longitudinal and randomized study has been proposed in a population of the EP who will undergo elective urology and coloproctology surgeries in two university hospitals (private and public).
The objective of this study is to evaluate how the implementation of a timely pre-surgical conditioning (APO) protocol for frail elderly people reduces the days of hospital stay.
The APO considers the most relevant aspects of physical and cardiovascular pre-habilitation, in addition to contemplating evaluations of frailty, dependence, cognitive status, screening for delirium, nutritional and metabolic.
Read the detailed description
A prospective, interventional, longitudinal and randomized study has been proposed in a population of the EP who will undergo elective urology and coloproctology surgeries in two university hospitals: Red de Salud UC-Christus and Hospital Clinico La Florida. Both based on Santiago de Chile.
The objective of this study is to evaluate how the implementation of a timely pre-surgical conditioning (APO) protocol for frail elderly people reduces the days of hospital stay.
PM will be screened according to: co-morbidities, degree of frailty and dependence. This procedure will be carried out by a trained register nurse (RN) from the team at each center, who through a random system will enter 50% of the patients to the APO protocol (intervention) and the other 50% to the standard protocol of each institution. After that the RN will measure nutritional and cognitive status, drugs and alcohol consume and will take the protocol blood samples in the first evaluation two to three days after receiving an order for surgery for the physician.
The APO considers the evaluations for a geriatric team, physical therapist team and nutritionist team in order to find out the most relevant aspects of physical, cardiovascular geriatric syndromes, cognitive status, nutritional and metabolic status.
physical therapist team and nutritionist team they will prepare to the EP to surgery with physical, cardiovascular and dietary protocols adjusted to the patient, for the time of 4 to 5 weeks before surgery.
Upon admission of hospitalization for surgery, the RN in each of the two hospitals will evaluate the state of frail and dependence, nutritional and cognitive status, drugs and alcohol consume and delirium status in which the patients of both groups arrive.
The analgesia and anesthesia of all patients in both groups, control and intervention, will be standardized to reduce confounding associated with intra- and postoperative anesthesia and analgesia.
The registered nurse will follow the patient throughout the in-hospital process and via telemedicine or face-to-face will interview patients one month, second month and third month after discharge in search of possible problems associated with the peri-operative process.
- Conditions
- Surgery, Old Age; Debility, Frail Elderly Syndrome, Post-Operative Confusion, Older Adults, Perioperative Care
- Being tested
- Timely pre-surgical conditioning
- Keywords
- Older adults, Perioperative Care, Frail Elderly Syndrome, Pre-habilitation, length of stay in hospital
- Medical subject headings
- Frailty, Urologic Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timely pre-surgical conditioningOther
Timely pre-surgical conditioning seeks to prepare frail, pre-frail and / or dependent older patients for the surgery process. For which a work plan has been designed according to your needs and health conditions.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will have a nursing evaluation and then follow the surgeon's instructions in the current standard way until de surgery day. In that day the RN will be evaluate again these group. Then, this group will be followed within the hospital and the first, second and third month after discharge. |
| Intervention | Experimental | The intervention group will have a nursing evaluation and then will attend an evaluation by geriatarics team, kinesiology and nutrition, where a plan of physical cardiovascular, nutritional and metabolic prehabilitation is delivered. On the day of surgery, the RN will evaluate this group again. Then, this group will be followed within the hospital and the first, second and third month after discharge. Receives: Other: Timely pre-surgical conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Reduction of length of hospital stay in terms of days after surgery of frail elderly enrolled in the control and intervention arm.
Measured: Average of 5 to Days of hospital stay until discharge after surgery
Change of the degree of the frailty in the elderly patients during the perioperative process
Change from Baseline in the degree of preoperative frailty in the elderly patients in both arms with Frail Scale 0= Robust, 1= Pre - Frail, 3-5 = Frail; Fried phenotype of frailty 0= Robust, 1= Pre - Frail, 3-5 = Frail and Clinical Frail Scale 1 to 9, 1 is very fit and 9 is a terminal patients.
Measured: One month before surgery, the 1 day of the surgery up to 3 months after discharge.
Change of the nutritional and metabolic status in the elderly patients during the perioperative process
Change from Baseline in the nutritional and metabolic status in the in the elderly patients in both arms measure with the Mini Nutritional Assessment scale.
12-14 points: Normal nutritional status 8-11 points: At risk of malnutrition 0-7 points: Malnourished
Measured: One month before surgery, the 1 day of the surgery up to 3 months after discharge.
Assessment functional independence in the elderly patients preoperative and postoperative
Assessment functional independence with the Barthel Index for Activities of Daily Living. 0 to 100. 0 is Totally dependent and 100 totally independent
Measured: One month before surgery, the 1 day of the surgery up to 3 months after discharge.
Change of the cardiorespiratory and muscular system in the elderly patients during the perioperative process
Change from Baseline of the cardiorespiratory and muscular system in the elderly patients before and after surgery with Short Physical Performance Battery (Score 0 - 12, 0 = lower physical performance and 12 = higher physical performance); 6 Minute Walk Test (ranges from 400 to 700 m, the main predictor variables being gender, age and height) or 2 minute step Test (record the total number of times the right knee reaches the tape level in two minutes. The recommended ranges for this test based on age groups from Jones \& Rikli, 2002).
Measured: One month before surgery, the 1 day of the after surgery up to 3 days post surgery.
Secondary outcomes (4)
Change of the cognitive state in the elderly patients during the perioperative process
Change of the cognitive state in the elderly patients during the perioperative process with Mini Cog test (0-2 points indicates positive screen for dementia and 3-5 points indicates negative screen for dementia); AD8 (0 to 8, and over 2 is positive for dementia), and/or MoCA test (scores range between 0 and 30. A score of 26 or over is considered to be normal).
Measured: One month before surgery, the 1 day of the surgery up to 3 months after discharge.
Identify the appearance during the perioperative process of the delirum in the elderly patients
Identify the appearance during the perioperative process of the delirum in the elderly patients with Confusion assessment method (CAM), CAM=negative is delirium absent and CAM=positive is delirum present, the same for CAM-Intensive Care Unit (CAM-ICU) CAM-ICU=negative is delirium absent and CAM-ICU=positive is delirum present.
Measured: 1 day before surgery and every day every 12 hours post surgery until discharge
Identify morbidity and post-operative complications
Identify post-operative complications with Claven-Dindo classification. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V).
Measured: Identify morbidity and mortality and post-operative complications one, two and three month after surgery discharge
Identify the mortality post-operative
Identify the mortality post-operative in the frail elderly enrolled in the controls and intervention arm.
Proportion of deaths from a certain of frail elderly patients after surgery compared to the total number of elderly people after surgery
Measured: One, two and three month after surgery discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start30 May 2021
- Primary completion30 Oct 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled, longitudinal.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Contreras, MSN, Pontificia Universidad Catolica de Chile
- Investigators
- Maria F Elgueta, MD, Principal investigator, Assistant Profesor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770259
- Sponsor's protocol ID
- 200302001
- Acronym
- APOPM
- Status last verified
- Dec 2023
- First submitted
- 15 Feb 2021
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Timely pre-surgical conditioning protocol for frail older people.
Publications
Edelmuth SVCL, Sorio GN, Sprovieri FAA, Gali JC, Peron SF. Comorbidities, clinical intercurrences, and factors associated with mortality in elderly patients admitted for a hip fracture. Rev Bras Ortop. 2018 Aug 2;53(5):543-551. doi: 10.1016/j.rboe.2018.07.014. eCollection 2018 Sep-Oct.
PubMed 30245992Bolliger M, Kroehnert JA, Molineus F, Kandioler D, Schindl M, Riss P. Experiences with the standardized classification of surgical complications (Clavien-Dindo) in general surgery patients. Eur Surg. 2018;50(6):256-261. doi: 10.1007/s10353-018-0551-z. Epub 2018 Jul 24.
PubMed 30546385Beggs T, Sepehri A, Szwajcer A, Tangri N, Arora RC. Frailty and perioperative outcomes: a narrative review. Can J Anaesth. 2015 Feb;62(2):143-57. doi: 10.1007/s12630-014-0273-z. Epub 2014 Nov 25.
PubMed 25420470Ferris DK, Willet-Brown J, Martensen T, Farrar WL. Interleukin 3 stimulation of tyrosine kinase activity in FDC-P1 cells. Biochem Biophys Res Commun. 1988 Aug 15;154(3):991-6. doi: 10.1016/0006-291x(88)90237-9.
PubMed 3261586Contreras V, Elgueta MF, Balde D, Astaburuaga P, Carrasco M, Pedemonte JC, Nicoletti MN, Medina Diaz R, Franco S, Agurto R, Vivanco C, Figueroa C, Alamos M, Cuzmar Benitez V, Vargas B, Barraza B, Rematal C, Cortinez LI. Prehabilitation for Chilean frail elderly people - pre-surgical conditioning protocol - to reduce the length of stay: randomized control trial. Minerva Anestesiol. 2024 Dec;90(12):1098-1107. doi: 10.23736/S0375-9393.24.18245-4.
PubMed 39836361
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of a Pre-surgical Conditioning Protocol for Frail Elderly People in Order to Reduce Hospitalization Days.
- ClinicalTrials.gov ID
- NCT04770259
- Acronym / sponsor ID
- APOPM / 200302001
- Conditions
- Surgery, Old Age; Debility, Frail Elderly Syndrome, Post-Operative Confusion, Older Adults, Perioperative Care
- Keywords
- Older adults, Perioperative Care, Frail Elderly Syndrome, Pre-habilitation, length of stay in hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 25 Feb 2021 (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.
Elderly people (EP) have increased, as well as life expectancy at birth. In Chile there are more than 2 million 800 thousand EP, which corresponds to 1/6 of the Chilean population.
The EP have a higher disease burden and mortality when facing surgery and in the postoperative period.
Thus, this population frequently has longer hospital stays due to its degree of fragility, surgical complications or decompensation of its underlying pathologies, directly affecting health care systems.
An inadequate preparation of the EP prior to surgery determined that the requirements of in-hospital as well as out-of-hospital care are extended, with the consequent which entails a higher cost in health.
Current research underestimates the conditions of frailty and dependence in the EP. In addition, it is not routinely evaluated prior to surgery, as well as nutritional, metabolic, cognitive status and / or delirium screening is performed.
There are accelerated recovery programs, which relate their interventions to specific pathologies; however, the age of the person is not taken into account.
Surgical pre-habilitation interventions in the EP usually focus their efforts on physical and cardiovascular aspects, not including an integrative pre-surgical evaluation.
Based on the foregoing, a prospective, interventional, longitudinal and randomized study has been proposed in a population of the EP who will undergo elective urology and coloproctology surgeries in two university hospitals (private and public).
The objective of this study is to evaluate how the implementation of a timely pre-surgical conditioning (APO) protocol for frail elderly people reduces the days of hospital stay.
The APO considers the most relevant aspects of physical and cardiovascular pre-habilitation, in addition to contemplating evaluations of frailty, dependence, cognitive status, screening for delirium, nutritional and metabolic.
Detailed description
A prospective, interventional, longitudinal and randomized study has been proposed in a population of the EP who will undergo elective urology and coloproctology surgeries in two university hospitals: Red de Salud UC-Christus and Hospital Clinico La Florida. Both based on Santiago de Chile.
The objective of this study is to evaluate how the implementation of a timely pre-surgical conditioning (APO) protocol for frail elderly people reduces the days of hospital stay.
PM will be screened according to: co-morbidities, degree of frailty and dependence. This procedure will be carried out by a trained register nurse (RN) from the team at each center, who through a random system will enter 50% of the patients to the APO protocol (intervention) and the other 50% to the standard protocol of each institution. After that the RN will measure nutritional and cognitive status, drugs and alcohol consume and will take the protocol blood samples in the first evaluation two to three days after receiving an order for surgery for the physician.
The APO considers the evaluations for a geriatric team, physical therapist team and nutritionist team in order to find out the most relevant aspects of physical, cardiovascular geriatric syndromes, cognitive status, nutritional and metabolic status.
physical therapist team and nutritionist team they will prepare to the EP to surgery with physical, cardiovascular and dietary protocols adjusted to the patient, for the time of 4 to 5 weeks before surgery.
Upon admission of hospitalization for surgery, the RN in each of the two hospitals will evaluate the state of frail and dependence, nutritional and cognitive status, drugs and alcohol consume and delirium status in which the patients of both groups arrive.
The analgesia and anesthesia of all patients in both groups, control and intervention, will be standardized to reduce confounding associated with intra- and postoperative anesthesia and analgesia.
The registered nurse will follow the patient throughout the in-hospital process and via telemedicine or face-to-face will interview patients one month, second month and third month after discharge in search of possible problems associated with the peri-operative process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled, longitudinal.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will have a nursing evaluation and then follow the surgeon's instructions in the current standard way until de surgery day. In that day the RN will be evaluate again these group. Then, this group will be followed within the hospital and the first, second and third month after discharge. |
| Intervention | Experimental | Other: Timely pre-surgical conditioningThe intervention group will have a nursing evaluation and then will attend an evaluation by geriatarics team, kinesiology and nutrition, where a plan of physical cardiovascular, nutritional and metabolic prehabilitation is delivered. On the day of surgery, the RN will evaluate this group again. Then, this group will be followed within the hospital and the first, second and third month after discharge. |
Who may qualify
- Ages
- 65 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Elective surgery of urology and / or minimally invasive coloproctology under general anesthesia
- Pre-frail, frail patients.
- Patients with a moderate to severe degree of dependence
Key exclusion criteria (3 listed)
- Emergency surgery patients.
- Patients who are hospitalized prior to surgery for urgent reasons and / or complications from another surgery.
- Patients diagnosed with delirum, dementia or similar mental illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timely pre-surgical conditioningTimely pre-surgical conditioning seeks to prepare frail, pre-frail and / or dependent older patients for the surgery process. For which a work plan has been designed according to your needs and health conditions. | Other | Intervention |
Primary outcome
Length of hospital stay
Time frame: Average of 5 to Days of hospital stay until discharge after surgery
Reduction of length of hospital stay in terms of days after surgery of frail elderly enrolled in the control and intervention arm.
Change of the degree of the frailty in the elderly patients during the perioperative process
Time frame: One month before surgery, the 1 day of the surgery up to 3 months after discharge.
Change from Baseline in the degree of preoperative frailty in the elderly patients in both arms with Frail Scale 0= Robust, 1= Pre - Frail, 3-5 = Frail; Fried phenotype of frailty 0= Robust, 1= Pre - Frail, 3-5 = Frail and Clinical Frail Scale 1 to 9, 1 is very fit and 9 is a terminal patients.
Change of the nutritional and metabolic status in the elderly patients during the perioperative process
Time frame: One month before surgery, the 1 day of the surgery up to 3 months after discharge.
Change from Baseline in the nutritional and metabolic status in the in the elderly patients in both arms measure with the Mini Nutritional Assessment scale. 12-14 points: Normal nutritional status 8-11 points: At risk of malnutrition 0-7 points: Malnourished
Assessment functional independence in the elderly patients preoperative and postoperative
Time frame: One month before surgery, the 1 day of the surgery up to 3 months after discharge.
Assessment functional independence with the Barthel Index for Activities of Daily Living. 0 to 100. 0 is Totally dependent and 100 totally independent
Change of the cardiorespiratory and muscular system in the elderly patients during the perioperative process
Time frame: One month before surgery, the 1 day of the after surgery up to 3 days post surgery.
Change from Baseline of the cardiorespiratory and muscular system in the elderly patients before and after surgery with Short Physical Performance Battery (Score 0 - 12, 0 = lower physical performance and 12 = higher physical performance); 6 Minute Walk Test (ranges from 400 to 700 m, the main predictor variables being gender, age and height) or 2 minute step Test (record the total number of times the right knee reaches the tape level in two minutes. The recommended ranges for this test based on age groups from Jones \& Rikli, 2002).
4 secondary outcomes
Change of the cognitive state in the elderly patients during the perioperative process
Time frame: One month before surgery, the 1 day of the surgery up to 3 months after discharge.
Identify the appearance during the perioperative process of the delirum in the elderly patients
Time frame: 1 day before surgery and every day every 12 hours post surgery until discharge
Identify morbidity and post-operative complications
Time frame: Identify morbidity and mortality and post-operative complications one, two and three month after surgery discharge
Identify the mortality post-operative
Time frame: One, two and three month after surgery discharge
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 14 Dec 2023.
- Background: PubMed 30245992Edelmuth SVCL, Sorio GN, Sprovieri FAA, Gali JC, Peron SF. Comorbidities, clinical intercurrences, and factors associated with mortality in elderly patients admitted for a hip fracture. Rev Bras Ortop. 2018 Aug 2;53(5):543-551. doi: 10.1016/j.rboe.2018.07.014. eCollection 2018 Sep-Oct.
- Background: PubMed 30546385Bolliger M, Kroehnert JA, Molineus F, Kandioler D, Schindl M, Riss P. Experiences with the standardized classification of surgical complications (Clavien-Dindo) in general surgery patients. Eur Surg. 2018;50(6):256-261. doi: 10.1007/s10353-018-0551-z. Epub 2018 Jul 24.
- Background: PubMed 25420470Beggs T, Sepehri A, Szwajcer A, Tangri N, Arora RC. Frailty and perioperative outcomes: a narrative review. Can J Anaesth. 2015 Feb;62(2):143-57. doi: 10.1007/s12630-014-0273-z. Epub 2014 Nov 25.
- Background: PubMed 3261586Ferris DK, Willet-Brown J, Martensen T, Farrar WL. Interleukin 3 stimulation of tyrosine kinase activity in FDC-P1 cells. Biochem Biophys Res Commun. 1988 Aug 15;154(3):991-6. doi: 10.1016/0006-291x(88)90237-9.
- Derived from this study: PubMed 39836361Contreras V, Elgueta MF, Balde D, Astaburuaga P, Carrasco M, Pedemonte JC, Nicoletti MN, Medina Diaz R, Franco S, Agurto R, Vivanco C, Figueroa C, Alamos M, Cuzmar Benitez V, Vargas B, Barraza B, Rematal C, Cortinez LI. Prehabilitation for Chilean frail elderly people - pre-surgical conditioning protocol - to reduce the length of stay: randomized control trial. Minerva Anestesiol. 2024 Dec;90(12):1098-1107. doi: 10.23736/S0375-9393.24.18245-4.
- Individual participant dataSharing planned: Yes. Timely pre-surgical conditioning protocol for frail older people.
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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.
Maria F Elgueta, MD principal investigator
Assistant Profesor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timely pre-surgical conditioning in people with Surgery and Old Age; Debility, run by Pontificia Universidad Catolica de Chile at 2 sites in Chile.
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 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. 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?
Length of hospital stay (time frame: Average of 5 to Days of hospital stay until discharge after surgery). The study lists 5 primary outcomes in all. 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 NCT04770259, which also lists 5 linked publications.
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 14 Dec 2023.