Prehabilitation Versus Enhanced Recovery Program for Elective Colorectal Cancer Surgery.

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Comparison of Preoperative Multimodal Preparation Program (Prehabilitation) With Enhanced Recovery Program for Elective Colorectal Cancer Surgery.

Conditions
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Colorectal Cancer, Insulin Resistance

Intervention / Treatment
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* Procedure: Prehabilitation + ERAS
* Procedure: ERAS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients planned for elective, curative operations for colorectal cancer will be randomized into two groups: experimental group will take part in a dedicated 4-week multimodal preparation program followed by ERAS preoperative management, while control group will just participate in the ERAS program without specific physical and mental preparation. 1:1 randomization will be performed.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation + ERAS<br>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. | Procedure: Prehabilitation + ERAS<br>* 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.<br>Procedure: ERAS<br>* Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation.<br>* Other names: Enhanced Recovery After Surgery Program;|
| Active Comparator: ERAS<br>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. | Procedure: ERAS<br>* Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation.<br>* Other names: Enhanced Recovery After Surgery Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Postoperative length of hospital stay in days. | within 45 days | 
| Number of days spent on ICU (Intensive care unit). | Number of days observed on ICU right after operation. | within 45 days postoperative | 
| Morbidity (early) classified after Clavien-Dindo. | 7-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed. | 7 days (until 8th postoperative day) postoperative | 
| Morbidity (long term) classified after Clavien-Dindo. | 30-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed. | 30 days (until 31st postoperative day) | 
| 30-day mortality | 30-day mortality of each patient will be recorded. | 30 days postoperative | 
| 90-day mortality | 90-day mortality of each patient will be recorded. | 90 days postoperative | 
| Change in preoperative functional status - 6MWD by operation | 6MWD (6-minute walking distance test) | Measured points: 4 weeks before surgery, on day of hospital admission | 
| Change in postoperative functional status - 6MWD by the end of rehabilitation | 6MWD (6-minute walking distance test) | Measured points: 4 weeks before surgery, 8 weeks after operation | 
| Change in preoperative functional status - FVC by operation | FVC (forced vital capacity) will be measured. | Measured points: 4 weeks before surgery, on day of hospital admission | 
| Change in preoperative functional status - FVC by the end of rehabilitation | FVC (forced vital capacity) will be measured. | Measured points: 4 weeks before surgery, 8 weeks after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay in beginning of adjuvant oncotherapy (chemotherapy, radiotherapy). | Sufficient recovery time until fitness of adjuvant chemo/radiotherapy will be recorded. | within 8 weeks, if adjuvant oncotherapy is needed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbidity, Mortality, Complication, Prehabilitation, ERAS