NCT Number: NCT04770259
Elderly people (EP) have increased, as well as life expectancy at birth. In Chile there are more than 2 million 800 thousand EP, which corresponds to 1/6 of the Chilean population.
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.
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Notify Me65 year–105 year
All sexes
Interventional
Not applicable
Hospital de La Florida, Santiago, Santiago Metropolitan, Chile
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: Red de Salud UC-Christus and Hospital Clinico La Florida. Both based on Santiago de Chile.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Average of 5 to Days of hospital stay until discharge after surgery
Reduction of length of hospital stay in terms of days after surgery of frail elderly enrolled in the control and intervention arm.
Time frame: One month before surgery, the 1 day of the surgery up to 3 months after discharge.
Change from Baseline in the degree of preoperative frailty in the elderly patients in both arms with Frail Scale 0= Robust, 1= Pre - Frail, 3-5 = Frail; Fried phenotype of frailty 0= Robust, 1= Pre - Frail, 3-5 = Frail and Clinical Frail Scale 1 to 9, 1 is very fit and 9 is a terminal patients.
Time frame: One month before surgery, the 1 day of the surgery up to 3 months after discharge.
Change from Baseline in the nutritional and metabolic status in the in the elderly patients in both arms measure with the Mini Nutritional Assessment scale.
12-14 points: Normal nutritional status 8-11 points: At risk of malnutrition 0-7 points: Malnourished
Time frame: One month before surgery, the 1 day of the surgery up to 3 months after discharge.
Assessment functional independence with the Barthel Index for Activities of Daily Living. 0 to 100. 0 is Totally dependent and 100 totally independent
Time frame: One month before surgery, the 1 day of the after surgery up to 3 days post surgery.
Change from Baseline of the cardiorespiratory and muscular system in the elderly patients before and after surgery with Short Physical Performance Battery (Score 0 - 12, 0 = lower physical performance and 12 = higher physical performance); 6 Minute Walk Test (ranges from 400 to 700 m, the main predictor variables being gender, age and height) or 2 minute step Test (record the total number of times the right knee reaches the tape level in two minutes. The recommended ranges for this test based on age groups from Jones & Rikli, 2002).
Time frame: One month before surgery, the 1 day of the surgery up to 3 months after discharge.
Change of the cognitive state in the elderly patients during the perioperative process with Mini Cog test (0-2 points indicates positive screen for dementia and 3-5 points indicates negative screen for dementia); AD8 (0 to 8, and over 2 is positive for dementia), and/or MoCA test (scores range between 0 and 30. A score of 26 or over is considered to be normal).
Time frame: 1 day before surgery and every day every 12 hours post surgery until discharge
Identify the appearance during the perioperative process of the delirum in the elderly patients with Confusion assessment method (CAM), CAM=negative is delirium absent and CAM=positive is delirum present, the same for CAM-Intensive Care Unit (CAM-ICU) CAM-ICU=negative is delirium absent and CAM-ICU=positive is delirum present.
Time frame: Identify morbidity and mortality and post-operative complications one, two and three month after surgery discharge
Identify post-operative complications with Claven-Dindo classification. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V).
Time frame: One, two and three month after surgery discharge
Identify the mortality post-operative in the frail elderly enrolled in the controls and intervention arm.
Proportion of deaths from a certain of frail elderly patients after surgery compared to the total number of elderly people after surgery
Pontificia Universidad Catolica de Chile
Other
Generation of a Pre-surgical Conditioning Protocol for Frail Elderly People in Order to Reduce Hospitalization Days.
Acronym: APOPM
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