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prehab-cspt: PREHABILITATION RECTAL CANCER DURING ADJUVANCY VS BEFORE SURGERY

Sponsor
Corporacion Parc Tauli (Other)
Overall Status
Recruiting
CT.gov ID
NCT03543514
Collaborator
(none)
70
Enrollment
2
Locations
37.8
Anticipated Duration (Months)
35
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Other: TRIMODAL PREHABILITATION

Detailed Description

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
70 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
STUDY ON THE EFFECT OF TRIMODAL PREHABILITATION IN PATIENTS SUBMITTED TO RECTAL SURGERY DURING ADJUVANCY OR BEFORE SURGERY
Actual Study Start Date :
Feb 2, 2022
Anticipated Primary Completion Date :
Aug 30, 2024
Anticipated Study Completion Date :
Mar 30, 2025

Arms and Interventions

Arm Intervention/Treatment
PREHABILITATION GROUP

Patients affected on Cold-rectal cancer who needs surgery. We made trimodal prehabilitation

Other: TRIMODAL PREHABILITATION
Trimodal prehabilitation application in the form of: Control with the 6-minute walking test and podometer of physical activity Dietary advice to be able to perform a hyperproteic diet Mindfullnes to improve the emotional level.
Other Names:
  • PHYSICAL INTERVENTION
  • NUTRITIONAL INTERVENTION
  • EMOTIONAL INTERVENTION

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Crompehension Complexity Index (CCI) [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.

    Secondary Outcome Measures

    1. Six minutes walking test (6-MWT) [30 days]

      Physical capacity

    2. Malnutrion Universal Screening Tool (MUST) [30 days]

      Nutritional condition

    3. Hospital Anxiety and Depression Scale (HADS) [30 days]

      Emotional capacity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient diagnosed with colorectal neoplasia

    • Need colorectal surgery with curative indication

    • Scheduled surgery

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Laura Mora López Sabadell Barcelona Spain 08208
    2 Laura Mora Löpez Sabadell Barcelona Spain 08208

    Sponsors and Collaborators

    • Corporacion Parc Tauli

    Investigators

    • Principal Investigator: Laura Mora, Dr., Hospital Universitari Parc Tauli

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Laura Mora-Lopez, DOCTOR, Corporacion Parc Tauli
    ClinicalTrials.gov Identifier:
    NCT03543514
    Other Study ID Numbers:
    • PREHAB-CSPT
    First Posted:
    Jun 1, 2018
    Last Update Posted:
    Mar 21, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Laura Mora-Lopez, DOCTOR, Corporacion Parc Tauli
    colon cancer, rectal cancer, prehabilitation
    Additional relevant MeSH terms:
    Rectal Neoplasms

    Study Results

    No Results Posted as of Mar 21, 2022