Skip to content

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

Effect of Prehabilitation on the Lean Mass Index (IMM) in Patients Operated on for Colon Cancer in ERAS Programm.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03618329
Acronym
PRERAS
Enrollment
130
Registered
2018-08-07
Start date
2018-10-01
Completion date
2019-12-30
Last updated
2018-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colo-rectal Cancer, Nutrition Disorders

Keywords

COLON CANCER, ERAS, NUTRITION

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.

Interventions

OTHERPrehabilitation

exercise, nutrition and anxiety reduction in the preoperative period

Sponsors

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Effect of prehabilitation on the change from lean mass indexpreoperative and 1-month postoperativeEffect of prehabilitation on the lean mass index

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026