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| Name | Class |
|---|---|
| St. Borbala Hospital, Department of Surgery | UNKNOWN |
| Semmelweis University | OTHER |
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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.
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
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:
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:
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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation + ERAS | Experimental | Patients receiving a formal preoperative preparation on:
Each patient will be treated in an ERAS program preoperatively. |
|
| ERAS | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation + ERAS | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Balázs Bánky, PhD | Department of Surgery, St. Borbala Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, St. Borbala Hospital | Tatabánya | 2800 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30266205 | Background | Souwer ETD, Bastiaannet E, de Bruijn S, Breugom AJ, van den Bos F, Portielje JEA, Dekker JWT. Comprehensive multidisciplinary care program for elderly colorectal cancer patients: "From prehabilitation to independence". Eur J Surg Oncol. 2018 Dec;44(12):1894-1900. doi: 10.1016/j.ejso.2018.08.028. Epub 2018 Sep 8. | |
| 29327644 | Background |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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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.
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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.
| ERAS | Procedure | Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation. |
|
|
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 |
| Bousquet-Dion G, Awasthi R, Loiselle SE, Minnella EM, Agnihotram RV, Bergdahl A, Carli F, Scheede-Bergdahl C. Evaluation of supervised multimodal prehabilitation programme in cancer patients undergoing colorectal resection: a randomized control trial. Acta Oncol. 2018 Jun;57(6):849-859. doi: 10.1080/0284186X.2017.1423180. Epub 2018 Jan 12. |
| 27539131 | Background | Chen BP, Awasthi R, Sweet SN, Minnella EM, Bergdahl A, Santa Mina D, Carli F, Scheede-Bergdahl C. Four-week prehabilitation program is sufficient to modify exercise behaviors and improve preoperative functional walking capacity in patients with colorectal cancer. Support Care Cancer. 2017 Jan;25(1):33-40. doi: 10.1007/s00520-016-3379-8. Epub 2016 Aug 18. |
| 27913000 | Background | Carli F, Silver JK, Feldman LS, McKee A, Gilman S, Gillis C, Scheede-Bergdahl C, Gamsa A, Stout N, Hirsch B. Surgical Prehabilitation in Patients with Cancer: State-of-the-Science and Recommendations for Future Research from a Panel of Subject Matter Experts. Phys Med Rehabil Clin N Am. 2017 Feb;28(1):49-64. doi: 10.1016/j.pmr.2016.09.002. |
| 29536753 | Background | Banky B, Lakatos M, Varga K, Hansagi E, Horvath E, Jaray G. [Enhanced Recovery Program in colorectal surgery]. Magy Seb. 2018 Mar;71(1):3-11. doi: 10.1556/1046.71.2018.1.1. Hungarian. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D015444 |
| Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |