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Prehabilitation Versus Enhanced Recovery Program for Elective Colorectal Cancer Surgery.

NCT03758209 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2020-03-17

No results posted yet for this study

Summary

Elective surgery is the most effective treatment option for colorectal cancer, however it has been recognized to be associated with high morbidity and mortality risks.

ERAS (Enhanced Recovery After Surgery) is a preoperative multimodality treatment package, which has been well investigated and proved to be effective in reducing early postoperative morbidity, mortality, length of hospital stay and hospital costs, as well. Still, a good proportion of patients are not suitable for ERAS program, mainly based on lack of compliance and the impaired physical function before surgery.

Prehabilitation Program is a recently introduced trimodal preoperative preparation (training) program, which addresses improvement of physical, mental and nutritional status of the high risk elective surgery patients.

This study aims to investigate the benefit of all efforts of a 4-6-week preoperative preparation program (Prehabilitation) being added to an established ERAS protocol.

Conditions

Interventions

PROCEDURE

Prehabilitation + ERAS

Prehabilitation will cover a range preoperative education and exercises (weekly) on diet, physical activity (daily walking), respiratory training (forced deep inspiration with spirometer device), as well as anxiolytic group psychotherapy.

PROCEDURE

ERAS

Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation.

Sponsors & Collaborators

  • St. Borbala Hospital, Department of Surgery

    collaborator UNKNOWN

  • Semmelweis University

    collaborator OTHER

  • St. Borbala Hospital

    lead OTHER_GOV

Principal Investigators

  • Balázs Bánky, PhD · Department of Surgery, St. Borbala Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-11-01
Completion
2019-11-01

Countries

  • Hungary

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03758209 on ClinicalTrials.gov