PRERAS: Effect of Prehabilitation on the Lean Mass Index (IMM) in ERAS PROGRAMM.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Prehabilitation exercise, nutrition and anxiety reduction in the preoperative period |
Other: Prehabilitation
exercise, nutrition and anxiety reduction in the preoperative period
|
| No Intervention: No Prehabilitation Not: exercise, nutrition and anxiety reduction in the preoperative period |
Outcome Measures
Primary Outcome Measures
- Effect of prehabilitation on the change from lean mass index [preoperative and 1-month postoperative]
Effect of prehabilitation on the lean mass index
Eligibility Criteria
Criteria
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.
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The subject is ≥ 18 years of age.
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The subject can perform any of the two proposed treatments.
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Preoperative staging TxNxM0.
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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:
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Patients with rectal cancer.
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The study doctor determines that the subject is not eligible to participate.
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The subject can not give informed consent to participate in the study.
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The subject can not perform the pre-habilitation.
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Non-acceptance or impossibility of following rehabilitation protocol multimodal
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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
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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.
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Subject has renal or hepatic impairment (GFR <60ml / m or AST / ALT 3 x upper limit of normal).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRERAS