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

Not Applicable

• Conditions: Colo-rectal Cancer; Nutrition Disorders
• Interventions: Other: Prehabilitation

• Registration Number: NCT03618329
• Lead Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-31
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-04
• Last Update Submitted: 2018-08-04
• Study First Posted: 2018-08-07
• Last Update Posted: 2018-08-07
• Study Start: 2018-10-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prehabilitation	Prehabilitation	exercise, nutrition and anxiety reduction in the preoperative period

Primary Outcome Measures

Name	Time	Method
Effect of prehabilitation on the change from lean mass index	preoperative and 1-month postoperative	Effect of prehabilitation on the lean mass index