Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery. (Prehab_2)

St. Borbala Hospital

Status: Suspended

Conditions: Colorectal Cancer

Treatments: Procedure: Trimodal rehabilitation + ERAS; Procedure: ERAS + nutritional prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04595604

ERASvsPrehab_2

Details and patient eligibility

About

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.

Trimodal Prehabilitation Program is a recently introduced 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.

Additionally the effect of trimodal prehabilitation on gut microbiom diversity and its relation to clinical outcome will be analyzed.

Full description

Aim:

Colorectal cancer patients with a planned resection are tested if a complex, trimodal rehabilitation program can hold functional and morbidity benefit for them.

In the prospective, randomized (2:1) study control patient group will be the well established and tested ERAS (enhanced recovery after surgery) Program.

Study protocol in details:

First visit: Outpatient Department of Surgery

On both arms:

• History taking (including family history and oncologic history);
• Physical examination

Operation indication, type of procedure and date of procedure agreed; Organizing further investigations, anesthesia; Operative risk assessment ("ACS - surgical risk calculator"); Study patient identifier Nr generated; Nurse-led ERAS/Prehab clinic: randomization

On both arms:

• Randomization (Prehabilitation Program / ERAS Program). 2:1
• Nurse led clinic assessment ("study nurse"):

.i. CaseReportForm (CRF) filled in.

.ii. Patient data (personal data, demographics, history) .iii. Anthropometrics (BMI, MUST, Body fat % measurement). .iv. Mental hygienic status assessment (smoking, alcohol consumption, anxiety, depression, sleeping disorders).

.v. Cardiovascular status (resting HR, RR). .vi. Operative risk assessment (CR-Possum score). .vii. Preoperative counseling (operation type, preparation, pain management, discharge plan).

.viii. Preoperative nutritional planning (education, nutrient prescription). .ix. Alcohol intake and smoking cessation - information given. .x. Stoma education started. . xi. Consent signed, patient workbook handed over. .xii. Respiratory test referral. xiii. Fecal sample collected and stored at -86 C.

Physiotherapy, first visit

Both on control and interventional arms:

• Respiratory function test recorded.
• Physical status tested (6MWD) on a treadmill.

Just on Prehabilitation arm:

• Respiratory training education.
• Respiratory trainer device usage educated.
• Daily activity (walking) planned.

Physiotherapy - second/third/fourth visit (weekly)

Just on Prehabilitation arm:

Previous week activity reviewed as to workbook. Physical assessment: 6MWD, FVC. Next week activity planned. Psychic preparation

Just on Prehabilitation arm:

• Once a week half an hour group relaxation training - regardless of the stage of prehabilitation program.

Admission to the Surgical Ward a day before surgery

Both on control and interventional arm:

• Preoperative assessment:

.i. Anthropometrics (BMI, body fat%). .ii. Cardiovascular stage (resting HR and RR), ECG. .iii. Respiratory function tests. .iv. Physical status (6MWD) .v. Mental status (Hospital Anxiety and Depression Scale (HADS)) assessment. vi. Fecal sample collected and stored at -86 C.

• Preoperative preparation (as to ERAS protocol).
• Postoperative care (ITU, pain management, mobilization, oral nutrition built up, drains early removal, complications recorded (Clavien-Dindo-classification)).
• Stoma education.

Dietary education. On discharge: Quality of Life (QoL) SF36 - (36-Item Short Form Survey from the RAND Medical Outcomes Study).

Postoperative follow up:

Both on control and interventional arms:

• Assessment (8th week post op.):

.i. Anthropometrics (BMI, Body fat %) .ii. Cardiovascular status (resting HR and RR). .iii. Respiratory function tests. .iv. Physical status (6MWD). .v. Fecal sample collected and stored at -86 C.

• Long-term follow-up: 12, 24, 36, 48 and 60 months post operative assessment: Behavioral changes (alcohol abstinence, smoking cessation) Daily physical activity routine assessment. SF36 quality of life assessment Oncological outcome: local recurrence rate, distant recurrence rate, disease free survival, overall survival.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient with histologically proven primary colorectal adenocarcinoma
• any stage of colorectal cancer
• elective operation
• curative intention
• informed consent signed by patient

Exclusion criteria

• emergency operation
• palliative operation
• non-colorectal, second malignancy
• pregnancy
• patient not giving consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Trimodal prehabilitation + ERAS

Experimental group

Description:

Patients receiving a formal preoperative preparation on: Physical status (walking, respiratory training) Nutrition (nutritional supplements) Mental status (weekly groups led by clinical psychologist on anxiety and depression management). Each patient will be treated in an ERAS program preoperatively.

Treatment:

Procedure: Trimodal rehabilitation + ERAS

ERAS + nutritional prehabilitation

Active Comparator group

Description:

Each patient will be treated in an ERAS program preoperatively. No specific preoperative training will be involved apart from nutritional status assessment and nutritional supplements.

Treatment:

Procedure: ERAS + nutritional prehabilitation