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RecruitingNCT06857981Updated Jun 10, 2025

Patient's Database: Prepare for Your Surgery Program

An observational study in Frailty in Adult Surgery, Frail Elderly Syndrome and Database, sponsored by Pontificia Universidad Catolica de Chile. Recruiting at 2 sites in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-10.

Sponsored by Pontificia Universidad Catolica de Chile · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started May 2025; still recruiting 1 year 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • Frailty in Adult Surgery
  • Frail Elderly Syndrome
  • Database
  • Perioperative Care
  • Prehabilitation

Browse trials for

Keywords

  • Database
  • Perioperative care
  • Prospective Studies
  • Frailty
  • Follow-Up Studies
  • Prehabilitation
03

In context

Frailty

1,199 studies on the registry are indexed under Frailty; 430 are open to participants now.

This study's planned enrollment of 120 is below the median of 223 across 496 observational studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • Patient's Data Base

    Patients referred to the Prepare for Your Surgery program

    Other: Clinical data collection

Interventions

  • OtherClinical data collection

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 1 month

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 3 - 6 months

07

Study locations

1 of 2 sites recruiting
  • Pontificia Universidad Católica de Chile
    Santiago, Región Metropolitana 8320000, Chile
    • Victor Contreras · Contact · vecontre@uc.cl
    • Victor Contreras · Principal investigator
    • María F Elgueta · Sub investigator
    Not yet recruiting
  • Red de Salud UC Christus
    Santiago, Chile
    • Victor Contreras, MSN, RN · Contact · vecontre@uc.cl · +56981895232
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06857981
Lead sponsor
Pontificia Universidad Catolica de Chile
Responsible party
Sponsor
First posted
Mar 5, 2025
Start date
May 21, 2025
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Jun 10, 2025

Study contacts

Victor Contreras, MSN
Contact
vecontre@uc.cl
+56955049217
Maria F Elgueta, MD
Contact
panchielgueta@gmail.com
+56223543414
Victor Contreras, MSN
principal investigator · Pontificia Universidad Catolica de Chile

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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