Clinical Trials Directory

Trials / Completed

CompletedNCT05057741

Surgical Prehabilitation in Abdominal Surgery

Surgical Prehabilitation of Patients Taken to Major Gastrointestinal Surgery.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Universidad del Rosario · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMultimodal prehabilitationPatients 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.

Timeline

Start date
2022-02-23
Primary completion
2023-06-22
Completion
2023-06-23
First posted
2021-09-27
Last updated
2024-06-14

Locations

1 site across 1 country: Colombia

Source: ClinicalTrials.gov record NCT05057741. Inclusion in this directory is not an endorsement.