Generation of a Pre-surgical Conditioning Protocol for Frail Elderly People in Order to Reduce Hospitalization Days.
| Registry | NCT04770259, acronym APOPM |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 87 (Actual) |
| Sponsor | Pontificia Universidad Catolica de Chile (Other) |
| Conditions | Surgery, Old Age; Debility, Frail Elderly Syndrome, Post-Operative Confusion, Older Adults, Perioperative Care, Urologic Diseases, Digestive Disease, Anesthesia, Nurse-Patient Relations |
| Interventions | Timely pre-surgical conditioning (Other) |
| Dates | start 2021-05-30, primary completion 2023-10-30, completion 2023-11-30, first posted 2021-02-25, last updated 2023-12-14 |
| Locations | 2 sites in Chile |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control | No intervention | 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. | |
| Intervention | Experimental | Other: Timely pre-surgical conditioning | 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. |
Sex: All, ages: 65 Years to 105 Years
Inclusion Criteria: * Elective surgery of urology and / or minimally invasive coloproctology under general anesthesia * Pre-frail, frail patients. * Patients with a moderate to severe degree of dependence Exclusion Criteria: * Emergency surgery patients. * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Pontificia Universidad Catolica de Chile | Santiago, Santiago Metropolitan | Chile | |
| Hospital de La Florida | Santiago, Santiago Metropolitan | Chile |