Clinical trial NCT06857981: Patient's Database: Prepare for Your Surgery Program
Official title: Patient's Database: Prepare for Your Surgery Program
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty in Adult Surgery
Frail Elderly Syndrome
Database
Perioperative Care
Prehabilitation
Keywords: Database
Perioperative care
Prospective Studies
Frailty
Follow-Up Studies
Prehabilitation
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Establishment of a database
timeFrame: 1 month
Secondary outcomes:
measure: Registry of in-hospital history
timeFrame: 1 month
measure: Patient Follow-Up
timeFrame: 3 - 6 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Pontificia Universidad Católica de Chile
state: Región Metropolitana
city: Santiago
country: Chile
facility: Red de Salud UC Christus
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Victor Contreras, MSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.