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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05057741
Other study ID # CEI DVO005 1567-CV1324
Secondary ID B- 17-2020
Status Completed
Phase N/A
First received
Last updated
Start date February 23, 2022
Est. completion date June 23, 2023

Study information

Verified date June 2024
Source Universidad del Rosario
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized clinical trial evaluating changes in functional capacity, postoperative complications and 30-day mortality in patients over 60 years of age undergoing major gastrointestinal surgery who participate in a multimodal prehabilitation program, compared to non-prehabilitated patients.


Description:

Introduction: A surgical procedure can have repercussions on the functionality and quality of life of patients, reducing their functional capacity by up to 40%; poor preoperative physical performance increases the risk of perioperative morbidity and mortality by 30% and prolongs functional recovery, increasing the hospital stay of the older adult. Prehabilitation is a preoperative intervention that improves the physical, psychological and nutritional condition of the patient to obtain a better postoperative recovery, mobility and functional independence. Objective: To evaluate changes in functional capacity, postoperative complications and 30-day mortality in patients over 60 years of age undergoing major gastrointestinal surgery who participate in a multimodal prehabilitation program (exercise, nutrition and relaxation). Methodology: Randomized clinical trial. Two study groups will be compared, an experimental group that will receive the educational intervention (multimodal prehabilitation program) and a control group that will continue with the usual management in the Hospital. The project activities will be carried out in Telehealth modality due to COVID-19 contagion containment measures. Expected results: To encourage interprofessional work based on common goals with standardization of data and processes to improve physical condition and reduce post-surgical complications; to establish traceability of care, clinical and functional condition of the patient. It is intended to generate scientific evidence, integrate the research groups Méderi, Rehabilitation Sciences and Clinical Research.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date June 23, 2023
Est. primary completion date June 22, 2023
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Patients scheduled by the General Surgery, Coloproctology and Hepatobiliary Surgery services - Cognitive ability to follow instructions, - Understand the material delivered (basic reading comprehension - through physical or digital media) - Perform physical exercise. - Aptitude to exercise according to the cardiovascular risk assessment performed by the treating physician. Exclusion Criteria: - Patients scheduled for surgery from the emergency department - Patients with sepsis, - Patients with metastatic disease, without curative perspective - Patients with dysphagia for solid foods - Patients with incapacitating psychiatric or neurological illnesses - Patients with documented previous immunosuppression status (corticosteroid users in the 6 weeks prior to the randomisation) and/or HIV - Diabetic patients, with chronic renal disease, stage 4-5, with renal replacement therapy - Patients with heart failure decompensated, or that limits the physical exercise - Patients with dependent mobility - Patients with history of second primary neoplasm

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Multimodal prehabilitation
Patients who will receive a multimodal prehabilitation program consisting of guided self-care activities at home that include exercise, nutrition and relaxation. Information Will be share by e health. Monitored by telephone daily during the first week and three times a week between the second and fourth week. The final evaluation of the program will be performed one working day after the control appointment with surgery, which will be scheduled ten days after hospital discharge; and the satisfaction survey will be applied. At 30 days after surgery, a telephone follow-up will be made to inquire about complications and mortality. On that day, self-care recommendations will be given.

Locations

Country Name City State
Colombia Hospital Universitario Mayor Mederi Bogota Distrito Capital

Sponsors (2)

Lead Sponsor Collaborator
Universidad del Rosario Hospital Universitario Mayor Mederi

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary functional capacity Changes in the maximum capacity to carry and use oxygen measured with the 2-minute stationary gait test (2MSG) One to six weeks
Secondary postoperative complications Presence of morbidities, whether or not requiring hospital readmission, generated by the surgical procedure 30 days
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