Surgical Prehabilitation in Abdominal Surgery (SPAS)

Surgical Prehabilitation of Patients Taken to Major Gastrointestinal Surgery.

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.

Study Overview

• Status: Completed
• Conditions: Older People; Prehabilitation; Surgical Procedure
• Intervention / Treatment: Behavioral: Multimodal prehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Distrito Capital
    • Bogota, Distrito Capital, Colombia
      • Hospital Universitario Mayor Méderi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal Prehabilitation; Multimodal prehabilitation: exercise, nutrition and relaxation	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.
No Intervention: Standard of Care; Usual care group: advice of surgeons about self care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications	Presence of morbidities, whether or not requiring hospital readmission, generated by the surgical procedure	30 days

Collaborators and Investigators

• Sponsor: Universidad del Rosario
• Collaborators: Hospital Universitario Mayor Méderi

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Actual): June 22, 2023
• Study Completion (Actual): June 23, 2023

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: exercise; nutritional; surgical procedure; functional condition
• Other Study ID Numbers: CEI DVO005 1567-CV1324; B- 17-2020 (Other Grant/Funding Number: Centro de Investigaciones Mederi CIMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No