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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Victor Contreras, MSN contact

+56955049217

vecontre@uc.cl

Maria F Elgueta, MD contact

+56223543414

panchielgueta@gmail.com

Chile2 sites, 2 recruiting
  • Pontificia Universidad Católica de Chile

    Santiago, Santiago Metropolitan, 8320000

    Victor Contreras, vecontre@uc.cl

    Victor Contreras

    Not yet recruiting
  • Red de Salud UC Christus

    Santiago

    Victor Contreras, MSN, RN, +56981895232, vecontre@uc.cl

    Recruiting

Other trials in Chile

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:

  1. 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).
  2. 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).
  3. 8 to 10 kinesiology evaluation and intervention sessions will be carried out according to the physical-functional status of the patient.
  4. 1 to 2 nutritional interventions will be carried out on physical-functional nutritional-metabolic status.
  5. 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.
  6. 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.
  7. 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.

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 groups in NCT06857981
Study groupRoleWhat they receive
Patient's Data BasePatients 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted5 Mar 2025
  2. Study start21 May 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

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
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 39603851
  • Gillis 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 35012741
  • Contreras 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

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; AzTrials last refreshed its copy on 27 Oct 2026.

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