Prehabilitation Versus Enhanced Recovery Program for Elective Colorectal Cancer Surgery.

NCT03758209 | Completed

• 1 other identifier: 48931-2/2018/EKU ETT-TUKEB
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Insulin Resistance

Keywords

Morbidity, Mortality, Complication, Prehabilitation, ERAS

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (1)

• Delay in beginning of adjuvant oncotherapy (chemotherapy, radiotherapy).

  within 8 weeks, if adjuvant oncotherapy is needed

Study Arms (2)

Prehabilitation + ERAS

EXPERIMENTAL

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; Procedure: ERAS

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.

Procedure: ERAS

Interventions

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.

Prehabilitation + ERAS

ERAS PROCEDURE

Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation.

Also known as: Enhanced Recovery After Surgery Program

ERAS; Prehabilitation + ERAS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient with histologically proven primary colorectal adenocarcinoma
• any stage of colorectal cancer
• elective operation
• curative intention
• informed consent signed by patient

You may not qualify if:

• emergency operation
• palliative operation
• non-colorectal, second malignancy
• pregnancy
• patient not giving consent

Sponsors & Collaborators

• St. Borbala Hospital: lead
• St. Borbala Hospital, Department of Surgery: collaborator
• Semmelweis University: collaborator

Study Sites (1)

Department of Surgery, St. Borbala Hospital

Tatabánya, 2800, Hungary

Location

Related Publications (5)

• 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.

  PMID: 30266205 BACKGROUND

• 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.

  PMID: 29327644 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.

  PMID: 27539131 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.

  PMID: 27913000 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.

  PMID: 29536753 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Insulin Resistance

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Balázs Bánky, PhD

  Department of Surgery, St. Borbala Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Surgery, St. Borbala Hospital

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

HU (1)