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Completed

NCT Number: NCT05057741

Surgical Prehabilitation in Abdominal 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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Mayor Mederi

Bogotá, Bogota D.C., Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. functional capacity

    Time frame: One to six weeks

    Changes in the maximum capacity to carry and use oxygen measured with the 2-minute stationary gait test (2MSG)

Secondary outcomes

  1. postoperative complications

    Time frame: 30 days

    Presence of morbidities, whether or not requiring hospital readmission, generated by the surgical procedure

Sponsors and collaborators

Lead sponsor

Universidad del Rosario

Other

Collaborators

  • Hospital Universitario Mayor Mederi

Registry information

Official study title

Surgical Prehabilitation of Patients Taken to Major Gastrointestinal Surgery.

Acronym: SPAS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 27, 2021
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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