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临床试验/NCT05057741
NCT05057741已完成不适用

Surgical Prehabilitation of Patients Taken to Major Gastrointestinal Surgery.

Universidad del Rosario1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
functional capacity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

functional capacity

时间窗: One to six weeks

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

次要结局

  • postoperative complications(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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