Prehabilitation Versus Enhanced Recovery Program for Elective Colorectal Cancer Surgery. (PrehabVsERAS)

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Insulin Resistance
• Intervention / Treatment: Procedure: Prehabilitation + ERAS; Procedure: ERAS

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).

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Tatabánya, Hungary, 2800
    • Department of Surgery, St. Borbala Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prehabilitation + ERAS; 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; 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.; Procedure: ERAS; Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation.; Other Names: Enhanced Recovery After Surgery Program
Active Comparator: ERAS; 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; Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation.; Other Names: Enhanced Recovery After Surgery Program

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Borbala Hospital
• Collaborators: Semmelweis University; St. Borbala Hospital, Department of Surgery
• Investigators: Study Director: Balázs Bánky, PhD, Department of Surgery, St. Borbala Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Morbidity, Mortality, Complication, Prehabilitation, ERAS
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Hyperinsulinism; Colorectal Neoplasms; Insulin Resistance
• Other Study ID Numbers: 48931-2/2018/EKU ETT-TUKEB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No