NCT06857981

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started May 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
May 2025Jun 2026

First Submitted

Initial submission to the registry

February 24, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 21, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

February 24, 2025

Last Update Submit

June 5, 2025

Conditions

Keywords

DatabasePerioperative careProspective StudiesFrailtyFollow-Up StudiesPrehabilitation

Outcome Measures

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.

    1 month

Secondary Outcomes (2)

  • Registry of in-hospital history

    1 month

  • Patient Follow-Up

    3 - 6 months

Study Arms (1)

Patient's Data Base

Patients referred to the Prepare for Your Surgery program

Other: Clinical data collection

Interventions

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.

Patient's Data Base

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, 8320000, Chile

NOT YET RECRUITING

Red de Salud UC Christus

Santiago, Chile

RECRUITING

Related Publications (3)

  • 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.

    PMID: 39603851BACKGROUND
  • 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.

    PMID: 35012741BACKGROUND
  • 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.

    PMID: 39836361BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Victor Contreras, MSN

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Contreras, MSN

CONTACT

Maria F Elgueta, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2025

First Posted

March 5, 2025

Study Start

May 21, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations