Surgical Prehabilitation in Abdominal Surgery
- Conditions
- PrehabilitationOlder PeopleSurgical Procedure
- Interventions
- Behavioral: Multimodal prehabilitation
- Registration Number
- NCT05057741
- Lead Sponsor
- Universidad del Rosario
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multimodal Prehabilitation Multimodal prehabilitation Multimodal prehabilitation: exercise, nutrition and relaxation
- Primary Outcome Measures
Name Time Method functional capacity One to six weeks Changes in the maximum capacity to carry and use oxygen measured with the 2-minute stationary gait test (2MSG)
- Secondary Outcome Measures
Name Time Method postoperative complications 30 days Presence of morbidities, whether or not requiring hospital readmission, generated by the surgical procedure
Trial Locations
- Locations (1)
Hospital Universitario Mayor Mederi
🇨🇴Bogota, Distrito Capital, Colombia