Effect of Prehabilitation on the Lean Mass Index (IMM) in ERAS PROGRAMM.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-12-30

Brief Summary

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The implementation of prehabilitation in patients operated on for colon cancer in a multimodal rehabilitation regimen improves the values of the "lean body mass" or lean mass index, positively influencing the results of clinical, analytical and radiological nutritional values pre- and postoperatively and in morbi-mortality, recovery, average stay and re-entry rates.

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Detailed Description

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Conditions

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Colo-rectal Cancer Nutrition Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Prehabilitation

exercise, nutrition and anxiety reduction in the preoperative period

Group Type ACTIVE_COMPARATOR

Prehabilitation

Intervention Type OTHER

exercise, nutrition and anxiety reduction in the preoperative period

No Prehabilitation

Not: exercise, nutrition and anxiety reduction in the preoperative period

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prehabilitation

exercise, nutrition and anxiety reduction in the preoperative period

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* It is considered that the subject suffers a confirmed diagnosis of colon cancer and is going to undergo surgery on a scheduled basis under a RHMM program.
* The subject is ≥ 18 years of age.
* The subject can perform any of the two proposed treatments.
* Preoperative staging TxNxM0.
* The patient has voluntarily signed and dated an informed consent document (IC), approved by an independent Ethics Committee (CEIC) before participating in the study.

Exclusion Criteria

* Patients with rectal cancer.
* The study doctor determines that the subject is not eligible to participate.
* The subject can not give informed consent to participate in the study.
* The subject can not perform the pre-habilitation.
* Non-acceptance or impossibility of following rehabilitation protocol multimodal
* The subject was previously scheduled at the time of the inclusion of the nutritional supplement study, whether it is different or the same that would be scheduled at this time
* Subjects who have received previous radiochemotherapy, HIV, gestational stage, psychiatric, with CRF who are undergoing renal replacement techniques, urgent surgery, with intestinal obstructions, with uncontrolled infections, urgent surgery, distant metastasis, ASA IV, advanced liver failure, severe coagulation disorder, severe hyperlipidemia and hyperglycemia or difficult to control.
* Subject has renal or hepatic impairment (GFR \<60ml / m or AST / ALT 3 x upper limit of normal).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No