Prehabilitation Versus Enhanced Recovery Program for Elective 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 (1:1) 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).

• 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.

• 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.

• 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 (4th and 8th week post op.):

.i. Anthropometrics (BMI, Body fat %) .ii. Cardiovascular status (resting HR and RR). .iii. Respiratory function tests. .iv. Physical status (6MWD).

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