Pre-surgical Protocol for Frail Elderly People in Order to Reduce Hospitalization Days (APOPM).
NCT ID: NCT04770259
Last Updated: 2023-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
87 participants
INTERVENTIONAL
2021-05-30
2023-11-30
Brief Summary
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The EP have a higher disease burden and mortality when facing surgery and in the postoperative period.
Thus, this population frequently has longer hospital stays due to its degree of fragility, surgical complications or decompensation of its underlying pathologies, directly affecting health care systems.
An inadequate preparation of the EP prior to surgery determined that the requirements of in-hospital as well as out-of-hospital care are extended, with the consequent which entails a higher cost in health.
Current research underestimates the conditions of frailty and dependence in the EP. In addition, it is not routinely evaluated prior to surgery, as well as nutritional, metabolic, cognitive status and / or delirium screening is performed.
There are accelerated recovery programs, which relate their interventions to specific pathologies; however, the age of the person is not taken into account.
Surgical pre-habilitation interventions in the EP usually focus their efforts on physical and cardiovascular aspects, not including an integrative pre-surgical evaluation.
Based on the foregoing, a prospective, interventional, longitudinal and randomized study has been proposed in a population of the EP who will undergo elective urology and coloproctology surgeries in two university hospitals (private and public).
The objective of this study is to evaluate how the implementation of a timely pre-surgical conditioning (APO) protocol for frail elderly people reduces the days of hospital stay.
The APO considers the most relevant aspects of physical and cardiovascular pre-habilitation, in addition to contemplating evaluations of frailty, dependence, cognitive status, screening for delirium, nutritional and metabolic.
Detailed Description
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The objective of this study is to evaluate how the implementation of a timely pre-surgical conditioning (APO) protocol for frail elderly people reduces the days of hospital stay.
PM will be screened according to: co-morbidities, degree of frailty and dependence. This procedure will be carried out by a trained register nurse (RN) from the team at each center, who through a random system will enter 50% of the patients to the APO protocol (intervention) and the other 50% to the standard protocol of each institution. After that the RN will measure nutritional and cognitive status, drugs and alcohol consume and will take the protocol blood samples in the first evaluation two to three days after receiving an order for surgery for the physician.
The APO considers the evaluations for a geriatric team, physical therapist team and nutritionist team in order to find out the most relevant aspects of physical, cardiovascular geriatric syndromes, cognitive status, nutritional and metabolic status.
physical therapist team and nutritionist team they will prepare to the EP to surgery with physical, cardiovascular and dietary protocols adjusted to the patient, for the time of 4 to 5 weeks before surgery.
Upon admission of hospitalization for surgery, the RN in each of the two hospitals will evaluate the state of frail and dependence, nutritional and cognitive status, drugs and alcohol consume and delirium status in which the patients of both groups arrive.
The analgesia and anesthesia of all patients in both groups, control and intervention, will be standardized to reduce confounding associated with intra- and postoperative anesthesia and analgesia.
The registered nurse will follow the patient throughout the in-hospital process and via telemedicine or face-to-face will interview patients one month, second month and third month after discharge in search of possible problems associated with the peri-operative process.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control
The control group will have a nursing evaluation and then follow the surgeon's instructions in the current standard way until de surgery day. In that day the RN will be evaluate again these group. Then, this group will be followed within the hospital and the first, second and third month after discharge.
No interventions assigned to this group
Intervention
The intervention group will have a nursing evaluation and then will attend an evaluation by geriatarics team, kinesiology and nutrition, where a plan of physical cardiovascular, nutritional and metabolic prehabilitation is delivered. On the day of surgery, the RN will evaluate this group again. Then, this group will be followed within the hospital and the first, second and third month after discharge.
Timely pre-surgical conditioning
Timely pre-surgical conditioning seeks to prepare frail, pre-frail and / or dependent older patients for the surgery process. For which a work plan has been designed according to your needs and health conditions.
Interventions
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Timely pre-surgical conditioning
Timely pre-surgical conditioning seeks to prepare frail, pre-frail and / or dependent older patients for the surgery process. For which a work plan has been designed according to your needs and health conditions.
Eligibility Criteria
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Inclusion Criteria
* Pre-frail, frail patients.
* Patients with a moderate to severe degree of dependence
Exclusion Criteria
* Patients who are hospitalized prior to surgery for urgent reasons and / or complications from another surgery.
* Patients diagnosed with delirum, dementia or similar mental illness.
65 Years
105 Years
ALL
No
Sponsors
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Pontificia Universidad Catolica de Chile
OTHER
Responsible Party
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Victor Contreras, MSN
Research associate
Principal Investigators
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Maria F Elgueta, MD
Role: PRINCIPAL_INVESTIGATOR
Assistant Profesor
Locations
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Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, Chile
Hospital de La Florida
Santiago, Santiago Metropolitan, Chile
Countries
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References
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Edelmuth SVCL, Sorio GN, Sprovieri FAA, Gali JC, Peron SF. Comorbidities, clinical intercurrences, and factors associated with mortality in elderly patients admitted for a hip fracture. Rev Bras Ortop. 2018 Aug 2;53(5):543-551. doi: 10.1016/j.rboe.2018.07.014. eCollection 2018 Sep-Oct.
Bolliger M, Kroehnert JA, Molineus F, Kandioler D, Schindl M, Riss P. Experiences with the standardized classification of surgical complications (Clavien-Dindo) in general surgery patients. Eur Surg. 2018;50(6):256-261. doi: 10.1007/s10353-018-0551-z. Epub 2018 Jul 24.
Beggs T, Sepehri A, Szwajcer A, Tangri N, Arora RC. Frailty and perioperative outcomes: a narrative review. Can J Anaesth. 2015 Feb;62(2):143-57. doi: 10.1007/s12630-014-0273-z. Epub 2014 Nov 25.
Ferris DK, Willet-Brown J, Martensen T, Farrar WL. Interleukin 3 stimulation of tyrosine kinase activity in FDC-P1 cells. Biochem Biophys Res Commun. 1988 Aug 15;154(3):991-6. doi: 10.1016/0006-291x(88)90237-9.
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.
Other Identifiers
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200302001
Identifier Type: -
Identifier Source: org_study_id