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

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.

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