Clinical trial NCT05057741: Surgical Prehabilitation in Abdominal Surgery
Official title: Surgical Prehabilitation of Patients Taken to Major Gastrointestinal Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older People
Prehabilitation
Surgical Procedure
Keywords: surgical procedure
exercise
nutritional
functional condition
Lead sponsor: Universidad del Rosario
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Mayor Mederi
First posted: 2021-09-27
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized clinical trial will be performed. 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. When the patient accepts to participate in the study and signs the informed consent, he/she will be evaluated by nutrition and physiotherapy. After the initial evaluation that confirms the selection criteria, the patient will be randomly assigned to the study groups, by means of a computer based randomisation program.

The evaluators of the initial and final conditions of the patients will not know the group to which each patient entering the study has been assigned. The study will be conducted following good clinical practice. The estimated duration of recruitment is sixteen months.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: functional capacity
timeFrame: One to six weeks
Secondary outcomes:
measure: postoperative complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Hospital Universitario Mayor Mederi
state: Distrito Capital
Study officials:
References: