PREHABILITATION RECTAL CANCER DURING ADJUVANCY VS BEFORE SURGERY (prehab-cspt)

March 6, 2022 updated by: Laura Mora-Lopez, Corporacion Parc Tauli

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Laura Mora López
        • Contact:
          • Laura Mora, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients affected by a colon or rectal tumor that have to undergo surgery.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crompehension Complexity Index (CCI)
Time Frame: 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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six minutes walking test (6-MWT)
Time Frame: 30 days
Physical capacity
30 days
Malnutrion Universal Screening Tool (MUST)
Time Frame: 30 days
Nutritional condition
30 days
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 30 days
Emotional capacity
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 2, 2022

Primary Completion (ANTICIPATED)

August 30, 2024

Study Completion (ANTICIPATED)

March 30, 2025

Study Registration Dates

First Submitted

April 26, 2018

First Submitted That Met QC Criteria

May 19, 2018

First Posted (ACTUAL)

June 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 6, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREHAB-CSPT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There's no plan to share IPD to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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