Surgical Prehabilitation in Abdominal Surgery

NCT05057741 | Completed DMC

• 2 other identifiers: CEI DVO005 1567-CV1324B- 17-2020
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Older People; Prehabilitation; Surgical Procedure

Keywords

surgical procedure; exercise; nutritional; functional condition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• postoperative complications

  30 days

Study Arms (2)

Multimodal Prehabilitation

EXPERIMENTAL

Multimodal prehabilitation: exercise, nutrition and relaxation

Behavioral: Multimodal prehabilitation

Standard of Care

NO INTERVENTION

Usual care group: advice of surgeons about self care

Interventions

Multimodal prehabilitation BEHAVIORAL

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.

Multimodal Prehabilitation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad del Rosario: lead
• Hospital Universitario Mayor Mederi: collaborator

Study Sites (1)

Hospital Universitario Mayor Mederi

Bogotá, Bogota D.C., Colombia

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: only the outcome assessor. at the time of reviewing the data and doing the analysis he was blinded to the data. No other form of blinding was used.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 27, 2021
• Study Start: February 23, 2022
• Primary Completion: June 22, 2023
• Study Completion: June 23, 2023
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)