Frailty in Adult SurgeryNCT06857981
Patient's Database: Prepare for Your Surgery Program
An observational study of Frailty in Adult Surgery and Frail Elderly Syndrome, run by Pontificia Universidad Catolica de Chile at 2 sites in Chile.
Trial summary
Frailty is a multidimensional syndrome that predominantly affects older people and people with long-term treatments such as cancer and chronic pain. This results in an increased risk of disability, reduced resistance and greater vulnerability to stressors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frailty in Adult Surgery, Frail Elderly Syndrome, Database
- What is being tested?
- Clinical data collection
- How many people
- 120 participants
- Where
- 2 sitesChile
- Study dates
- 21 May 2025to 30 Jun 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are users of the Hospital Clinico Red de Salud UC-Christus who are going to undergo elective surgery to be performed at the same center
Who may be able to join
- Patients referred to the Prepare for Your Surgery program
- Patients characterized as frail according to the Clinical Frailty Scale (score ≥ 4), FRAIL scale or FRIED frailty phenotype or the clinical judgment of the referring surgeon, with at least 4 weeks to receive surgery
- Elective surgery to be performed at Hospital Clinico Red de Salud UC-Christus
Who cannot join
- Patients who will not undergo elective surgery at Hospital Clínico Red de Salud UC-Christus.
- Patients who require emergency surgery
- Patients who for various reasons cannot comply with the interventions proposed for this preparation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chile2 sites, 2 recruiting
- Not yet recruiting
Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan, 8320000
Victor Contreras, vecontre@uc.cl
Victor Contreras
- Recruiting
Red de Salud UC Christus
Santiago
Victor Contreras, MSN, RN, +56981895232, vecontre@uc.cl
About this study
Frailty is a multidimensional syndrome that predominantly affects older people and people with long-term treatments such as cancer and chronic pain. This results in an increased risk of disability, reduced resistance and greater vulnerability to stressors.
These factors culminate in worse postoperative outcomes, including higher rates of complications and mortality. With the current demographic shift towards an aging population in Latin America and Chile, the prevalence of frailty among surgical patients is increasing.
Read more
Despite the clear association between frailty and adverse postoperative effects, in Chile there are few centers that routinely perform objective preoperative frailty assessment before to surgery. This is due to logistical challenges, the need for specialized training, and assessment tools. As a result, frailty remains an underestimated syndrome in the perioperative setting.
Various interventions have been proposed to improve the care of fragile surgical patients. Prehabilitation, a multidisciplinary program designed to prepare patients for surgery and improve their resilience to surgical stress, has emerged as a promising intervention. Recent studies indicate that prehabilitation may lead to shorter hospital length of stay (LOS) and fewer complications.
Recognizing the vital role that frailty plays in surgical outcomes and the paucity of research on prehabilitation, a prehabilitation or timely presurgical conditioning program (Prepare for Your Surgery Program) has been implemented at our center. This proposal seeks to optimize the patient before a surgical intervention in order to reduce frailty and complications, thus improving recovery and medium-term results.
The program consists of interventions 4 to 6 weeks before surgery focused on: nursing assessment, screening and follow-up, geriatric and/or internal medicine assessment and intervention, physiotherapy assessment and intervention, nutrition assessment and intervention, psychological assessment and intervention, and preoperative anesthesiology intervention.
For this purpose, it has been proposed to create a prospective database of patients from the Prepare for Your Surgery Program, who undergo elective surgery at Hospital Clinico Red Salud UC-Christus.
Read the detailed description
Potential participants in the "Prepare for Your Surgery" program must complete the informed consent process, having met the inclusion criteria for this database. Demographic data will be collected from patients, including: date of birth, age, gender/sex, pathology for which they were admitted, comorbidities, treatment they receive, and proposed interventions according to their initial evaluation. In turn, the episode number will be stored, whether their pathology is covered by the public health system through Explicit Health Guarantees (GES) or not, the number of days hospitalized associated with the surgical episode, specialty to which it corresponds, and the type of surgery according to code. From the clinical part, the data from your medical record will be stored, specifically, the results of the application of the following tests and index calculations.
Regarding the program, it consists mainly of 7 stages:
- An evaluation by the nurse navigator who will carry out the screenings defined by the treating team (in person or online). The instruments to be applied consist of the evaluation of frailty (Clinical Frailty Scale CFS, FRAIL Scale, FRIED phenotype); cognitive assessment using the Montreal Cognitive Assessment (MoCA) or Mini Cog; functionality (Barthel Index); Revised Cardiovascular Risk Index (Lee); Charlson Comorbidity Index nicotine dependence (Fageström Test); evaluation of obstructive sleep apnea (STOP Bang); stroke risk scale (CHAD VASc2); Respiratory failure index (Arozullah Respiratory Failure Index); Hospital Anxiety and Depression Scale (PHQ-2); evaluation of nutritional status (Mini Nutritional Assessment MNA); pain assessment (PROMIS pain); Physical Functioning Assessment (PROMIS PF), 6-Minute Walking Test, Grip Strength (Handgrip Test) and the Short Physical Performance Test (SPPT).
- A 30-minute outpatient medical consultation will be carried out that will focus on the evaluation and optimization of comorbidities, pre-surgical indications, request for examinations, referral to specialists, among others (in-person).
- 8 to 10 kinesiology evaluation and intervention sessions will be carried out according to the physical-functional status of the patient.
- 1 to 2 nutritional interventions will be carried out on physical-functional nutritional-metabolic status.
- If necessary, contact via email, telephone and/or telematics or with the results of the examinations will be used and define if a second consultation is justified, coordinated with the nurse navigator.
- Intra-hospital indicators will be recorded and monitored: days of hospitalization (surgical complications according to the Clavien Dindo classification or surgical risk indexes), daily in-hospital destination (basic care room, intermediate care room and/or ICU), until discharge.
- Post-hospital discharge follow-up will be carried out on complications, readmissions, mortality and/or relevant history of the patients for 3 to 6 months according to the surgical specialty.
The data to be obtained are clinically recorded and will be stored in the TrakCare program's own databases in the electronic record systems of the Hospital Clinico Red UC-CHRISTUS, surgical table (SAQ), SAP and other related systems. For data extraction, an encrypted data table associated with the "episode" numbering generated sequentially by the SAP care systems has been proposed. Each access to the "Patient Database: Prepare for Your Surgery Program" will be restricted by the team responsible for the database, which is accessed by means of a username and password with encrypted restrictions on the data generated.
To guarantee the confidentiality of the data, alternate identifiers will be used (example Male = 1, Female =2), which are codes associated with a case, which can bring together several episodes, to which numbers and letters are assigned, for which They are considered encrypted data without sensitive data. The encoded data can only be accessed by the responsible team who will guarantee the internal traceability of the data, safeguarding confidentiality and providing anonymized and/or encoded forms of the data collected. In addition, the data is kept linked to the clinical record servers which have their own backup and security systems within the services provided to the Hospital Clinico Red UC-CHRISTUS.
Once the number of participants is complete, the recorded data will be analyzed to describe the characteristics of the patients included in this type of program, evaluate key indicators such as adherence, participation and in the future generate improvements in implementation protocols, national or local policies and generate publications related to this topic.
- Conditions
- Frailty in Adult Surgery, Frail Elderly Syndrome, Database, Perioperative Care, Prehabilitation
- Being tested
- Clinical data collection
- Keywords
- Database, Perioperative care, Prospective Studies, Frailty, Follow-Up Studies, Prehabilitation
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical data collectionOther
Patient's data will be collected, including: date of birth, age, gender/sex, pathology for admission, comorbidities, treatment received, and proposed interventions based on initial assessment.
| Study group | Role | What they receive |
|---|---|---|
| Patient's Data Base | Patients referred to the Prepare for Your Surgery program Receives: Other: Clinical data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of a database
Establish a database to record the demographic characteristics, frailty and/or comorbidities and relevant preoperative history of patients referred to the "Prepare for your Surgery" program.
Measured: 1 month
Secondary outcomes (2)
Registry of in-hospital history
Record surgical, anesthetic, hospital stay and/or relevant in-hospital history of patients admitted to the "Prepare for Your Surgery" program.
Measured: 1 month
Patient Follow-Up
Record the characteristics of possible complications, rehospitalizations, mortality, and/or relevant histories of patients 3 to 6 months after hospital discharge, according to their surgical specialty.
Measured: 3 - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start21 May 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Frailty in Adult SurgeryStudies 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
- 120 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victor Contreras, MSN, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857981
- Sponsor's protocol ID
- 241120002
- Other IDs
- 241120002
- Status last verified
- Jun 2025
- First submitted
- 24 Feb 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gibbison B, Pufulete M. Prehabilitation before cardiac surgery. Br J Anaesth. 2025 Jan;134(1):5-7. doi: 10.1016/j.bja.2024.11.001. Epub 2024 Nov 26.
PubMed 39603851Gillis C, Ljungqvist O, Carli F. Prehabilitation, enhanced recovery after surgery, or both? A narrative review. Br J Anaesth. 2022 Mar;128(3):434-448. doi: 10.1016/j.bja.2021.12.007. Epub 2022 Jan 7.
PubMed 35012741Contreras 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 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient's Database: Prepare for Your Surgery Program
- ClinicalTrials.gov ID
- NCT06857981
- Acronym / sponsor ID
- 241120002
- Conditions
- Frailty in Adult Surgery, Frail Elderly Syndrome, Database, Perioperative Care, Prehabilitation
- Keywords
- Database, Perioperative care, Prospective Studies, Frailty, Follow-Up Studies, Prehabilitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 5 Mar 2025 (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 is a multidimensional syndrome that predominantly affects older people and people with long-term treatments such as cancer and chronic pain. This results in an increased risk of disability, reduced resistance and greater vulnerability to stressors.
These factors culminate in worse postoperative outcomes, including higher rates of complications and mortality. With the current demographic shift towards an aging population in Latin America and Chile, the prevalence of frailty among surgical patients is increasing.
Despite the clear association between frailty and adverse postoperative effects, in Chile there are few centers that routinely perform objective preoperative frailty assessment before to surgery. This is due to logistical challenges, the need for specialized training, and assessment tools. As a result, frailty remains an underestimated syndrome in the perioperative setting.
Various interventions have been proposed to improve the care of fragile surgical patients. Prehabilitation, a multidisciplinary program designed to prepare patients for surgery and improve their resilience to surgical stress, has emerged as a promising intervention. Recent studies indicate that prehabilitation may lead to shorter hospital length of stay (LOS) and fewer complications.
Recognizing the vital role that frailty plays in surgical outcomes and the paucity of research on prehabilitation, a prehabilitation or timely presurgical conditioning program (Prepare for Your Surgery Program) has been implemented at our center. This proposal seeks to optimize the patient before a surgical intervention in order to reduce frailty and complications, thus improving recovery and medium-term results.
The program consists of interventions 4 to 6 weeks before surgery focused on: nursing assessment, screening and follow-up, geriatric and/or internal medicine assessment and intervention, physiotherapy assessment and intervention, nutrition assessment and intervention, psychological assessment and intervention, and preoperative anesthesiology intervention.
For this purpose, it has been proposed to create a prospective database of patients from the Prepare for Your Surgery Program, who undergo elective surgery at Hospital Clinico Red Salud UC-Christus.
Detailed description
Potential participants in the "Prepare for Your Surgery" program must complete the informed consent process, having met the inclusion criteria for this database. Demographic data will be collected from patients, including: date of birth, age, gender/sex, pathology for which they were admitted, comorbidities, treatment they receive, and proposed interventions according to their initial evaluation. In turn, the episode number will be stored, whether their pathology is covered by the public health system through Explicit Health Guarantees (GES) or not, the number of days hospitalized associated with the surgical episode, specialty to which it corresponds, and the type of surgery according to code. From the clinical part, the data from your medical record will be stored, specifically, the results of the application of the following tests and index calculations.
Regarding the program, it consists mainly of 7 stages:
- An evaluation by the nurse navigator who will carry out the screenings defined by the treating team (in person or online). The instruments to be applied consist of the evaluation of frailty (Clinical Frailty Scale CFS, FRAIL Scale, FRIED phenotype); cognitive assessment using the Montreal Cognitive Assessment (MoCA) or Mini Cog; functionality (Barthel Index); Revised Cardiovascular Risk Index (Lee); Charlson Comorbidity Index nicotine dependence (Fageström Test); evaluation of obstructive sleep apnea (STOP Bang); stroke risk scale (CHAD VASc2); Respiratory failure index (Arozullah Respiratory Failure Index); Hospital Anxiety and Depression Scale (PHQ-2); evaluation of nutritional status (Mini Nutritional Assessment MNA); pain assessment (PROMIS pain); Physical Functioning Assessment (PROMIS PF), 6-Minute Walking Test, Grip Strength (Handgrip Test) and the Short Physical Performance Test (SPPT).
- A 30-minute outpatient medical consultation will be carried out that will focus on the evaluation and optimization of comorbidities, pre-surgical indications, request for examinations, referral to specialists, among others (in-person).
- 8 to 10 kinesiology evaluation and intervention sessions will be carried out according to the physical-functional status of the patient.
- 1 to 2 nutritional interventions will be carried out on physical-functional nutritional-metabolic status.
- If necessary, contact via email, telephone and/or telematics or with the results of the examinations will be used and define if a second consultation is justified, coordinated with the nurse navigator.
- Intra-hospital indicators will be recorded and monitored: days of hospitalization (surgical complications according to the Clavien Dindo classification or surgical risk indexes), daily in-hospital destination (basic care room, intermediate care room and/or ICU), until discharge.
- Post-hospital discharge follow-up will be carried out on complications, readmissions, mortality and/or relevant history of the patients for 3 to 6 months according to the surgical specialty.
The data to be obtained are clinically recorded and will be stored in the TrakCare program's own databases in the electronic record systems of the Hospital Clinico Red UC-CHRISTUS, surgical table (SAQ), SAP and other related systems. For data extraction, an encrypted data table associated with the "episode" numbering generated sequentially by the SAP care systems has been proposed. Each access to the "Patient Database: Prepare for Your Surgery Program" will be restricted by the team responsible for the database, which is accessed by means of a username and password with encrypted restrictions on the data generated.
To guarantee the confidentiality of the data, alternate identifiers will be used (example Male = 1, Female =2), which are codes associated with a case, which can bring together several episodes, to which numbers and letters are assigned, for which They are considered encrypted data without sensitive data. The encoded data can only be accessed by the responsible team who will guarantee the internal traceability of the data, safeguarding confidentiality and providing anonymized and/or encoded forms of the data collected. In addition, the data is kept linked to the clinical record servers which have their own backup and security systems within the services provided to the Hospital Clinico Red UC-CHRISTUS.
Once the number of participants is complete, the recorded data will be analyzed to describe the characteristics of the patients included in this type of program, evaluate key indicators such as adherence, participation and in the future generate improvements in implementation protocols, national or local policies and generate publications related to this topic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient's Data Base | – | Other: Clinical data collectionPatients referred to the Prepare for Your Surgery program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are users of the Hospital Clinico Red de Salud UC-Christus who are going to undergo elective surgery to be performed at the same center
Key inclusion criteria (3 listed)
- Patients referred to the Prepare for Your Surgery program
- Patients characterized as frail according to the Clinical Frailty Scale (score ≥ 4), FRAIL scale or FRIED frailty phenotype or the clinical judgment of the referring surgeon, with at least 4 weeks to receive surgery
- Elective surgery to be performed at Hospital Clinico Red de Salud UC-Christus
Key exclusion criteria (3 listed)
- Patients who will not undergo elective surgery at Hospital Clínico Red de Salud UC-Christus.
- Patients who require emergency surgery
- Patients who for various reasons cannot comply with the interventions proposed for this preparation.
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 |
|---|---|---|
| Clinical data collectionPatient's data will be collected, including: date of birth, age, gender/sex, pathology for admission, comorbidities, treatment received, and proposed interventions based on initial assessment. | Other | Patient's Data Base |
Primary outcome
Establishment of a database
Time frame: 1 month
Establish a database to record the demographic characteristics, frailty and/or comorbidities and relevant preoperative history of patients referred to the "Prepare for your Surgery" program.
2 secondary outcomes
Registry of in-hospital history
Time frame: 1 month
Patient Follow-Up
Time frame: 3 - 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Background: PubMed 39603851Gibbison B, Pufulete M. Prehabilitation before cardiac surgery. Br J Anaesth. 2025 Jan;134(1):5-7. doi: 10.1016/j.bja.2024.11.001. Epub 2024 Nov 26.
- Background: PubMed 35012741Gillis C, Ljungqvist O, Carli F. Prehabilitation, enhanced recovery after surgery, or both? A narrative review. Br J Anaesth. 2022 Mar;128(3):434-448. doi: 10.1016/j.bja.2021.12.007. Epub 2022 Jan 7.
- Background: 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: 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.
Victor Contreras, MSN principal investigator
Pontificia Universidad Catolica de Chile
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty in Adult Surgery and Frail Elderly Syndrome, 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: looking for participants now, as of the sponsor's last update on 10 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor Contreras, MSN (+56955049217, vecontre@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of a database (time frame: 1 month). 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 NCT06857981, which also lists 3 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 10 Jun 2025.