Colorectal Cancer, Insulin Resistance
Conditions
Keywords
Morbidity, Mortality, Complication, Prehabilitation, ERAS
Brief 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.
Detailed 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 (1:1) study control patient group will be the well established and tested ERAS (enhanced recovery after surgery) Program. Study protocol in details: 1. 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; 2. 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. 3. 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. 4. 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. 5. Psychic preparation Just on Prehabilitation arm: • Once a week half an hour group relaxation training - regardless of the stage of prehabilitation program. 6. 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). 7. 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).
Interventions
PROCEDUREPrehabilitation + 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.
PROCEDUREERAS
Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation.
Sponsors
St. Borbala Hospital, Department of Surgery
Semmelweis University
St. Borbala Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Investigators and assessors will be blinded regarding preoperative preparation. Both randomization process and rehabilitation process will be carried out by a trained nurse, physiotherapist and psychotherapist, neither of them will be involved in outcome assessment.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in preoperative functional status - FVC by the end of rehabilitation | Measured points: 4 weeks before surgery, 8 weeks after operation | FVC (forced vital capacity) will be measured. |
| Length of hospital stay | within 45 days | Postoperative length of hospital stay in days. |
| Number of days spent on ICU (Intensive care unit). | within 45 days postoperative | Number of days observed on ICU right after operation. |
| Morbidity (early) classified after Clavien-Dindo. | 7 days (until 8th postoperative day) postoperative | 7-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed. |
| Morbidity (long term) classified after Clavien-Dindo. | 30 days (until 31st postoperative day) | 30-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed. |
| 30-day mortality | 30 days postoperative | 30-day mortality of each patient will be recorded. |
| 90-day mortality | 90 days postoperative | 90-day mortality of each patient will be recorded. |
| Change in preoperative functional status - 6MWD by operation | Measured points: 4 weeks before surgery, on day of hospital admission | 6MWD (6-minute walking distance test) |
| Change in postoperative functional status - 6MWD by the end of rehabilitation | Measured points: 4 weeks before surgery, 8 weeks after operation | 6MWD (6-minute walking distance test) |
| Change in preoperative functional status - FVC by operation | Measured points: 4 weeks before surgery, on day of hospital admission | FVC (forced vital capacity) will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delay in beginning of adjuvant oncotherapy (chemotherapy, radiotherapy). | within 8 weeks, if adjuvant oncotherapy is needed | Sufficient recovery time until fitness of adjuvant chemo/radiotherapy will be recorded. |
Countries
Hungary
Outcome results
None listed