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临床试验/NCT03543514
NCT03543514招募中不适用

STUDY ON THE EFFECT OF TRIMODAL PREHABILITATION IN PATIENTS SUBMITTED TO RECTAL SURGERY DURING ADJUVANCY OR BEFORE SURGERY

Corporacion Parc Tauli2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
2
主要终点
Crompehension Complexity Index (CCI)

研究概览

简要总结

Preoperative preparation protocol (prehabilitation) for patients diagnosed with colorectal cancer who need surgery. It consists of a change in the preoperative preparation. The patient is an active part of their preparation and the professionals help to achieve a better functional capacity to diminish morbidity and accelerate recovery. Three levels are controlled:

  • Physical: control and stimulation to exercise at home.
  • Nutrition: control and advice through homemade recipes.
  • Emotional: control of the level of haste or depression and advice of mindfullness techniques at home.

If they need specific help they are derived from specialized professionals (rehabilitator, nutritionist / endocrinologist, psychologist).

详细描述

Protocol for colorectal neoplasia patients who need surgery by modifying the current one. Until now, in the preoperative time, the anesthetist evaluated the need for some specific action such as pre-operative iron administration to avoid perioperative transfusions or the need to assess some of the patient's morbidities to try to optimize it. In the perioperative period in our hospital, the criteria of the Multimodal and Fast-Tcack Rehabilitation programs have been applied for a long time and there are some trajectories that allow standardization of patient management once they have been admitted.

It is demonstrated in other centers and in other surgical pathologies that, in addition to what we are already applying to our center, modify the preoperative preparation of our patients and try to improve their "functional capacity" results of lower morbidity and mortality and the subsequent recovery of patients can greatly improve . This is called prehabilitation. Pretreatment consists in a change in preoperative preparation at three levels. The concept of preoperative preparation changes and the patient is actively involved in it. Three levels of the patient are controlled: functional or physical level, nutritional level and emotional level, by means of pots and they are encouraged to make a series of changes in their habitual life (exercise, dietary advice, mindfullness techniques) that increase its functional capacity. This is related to a decrease in morbidity and mortality and in addition to a better and faster postoperative recovery.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Patient diagnosed with colorectal neoplasia
  • Need colorectal surgery with curative indication
  • Scheduled surgery

排除标准

  • Patients who refuse to enter the study
  • Patients with indication of palliative surgery
  • Surgeries that involve colon and other organs
  • Urgent surgery
  • Basic pathology that does not allow to carry out some of the explorations necessary to carry out the trimodal pre-treatment.

结局指标

主要结局

Crompehension Complexity Index (CCI)

时间窗: 30 days

General morbidity due to the improvement of the physical capacity, the nutritional profile and the diminution of the psychic stroke can be diminished throughout the process and the return to the basal situation.

次要结局

  • Six minutes walking test (6-MWT)(30 days)
  • Malnutrion Universal Screening Tool (MUST)(30 days)
  • Hospital Anxiety and Depression Scale (HADS)(30 days)

研究者

发起方
Corporacion Parc Tauli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura Mora-Lopez

DOCTOR

Corporacion Parc Tauli

研究点 (2)

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