Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.

NCT04595604 | Completed

• 1 other identifier: ERASvsPrehab_2
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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. Trimodal Prehabilitation Program is a recently introduced 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. Additionally the effect of trimodal prehabilitation on gut microbiom diversity and its relation to clinical outcome will be analyzed.

Conditions

Colorectal Cancer

Keywords

ERAS; prehabilitation; fecal microbata

Outcome Measures

Primary Outcomes (10)

• Length of hospital stay

  Postoperative length of hospital stay in days.

  45 days

• Number of days spent on ICU (Intensive care unit).

  Number of days observed on ICU right after operation.

  45 days

• 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 (until 31st postoperative day)

• 90-day mortality

  90-day mortality of each patient will be recorded.

  90 days (until 91st postoperative day)

• 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

  Measured points: 4 weeks before surgery, on day of hospital admission

  Measured points: 4 weeks before surgery, on day of hospital admission

• Change in preoperative functional status - FVC by the end of rehabilitation

  Measured points: 4 weeks before surgery, 8 weeks after operation

  Measured points: 4 weeks before surgery, 8 weeks after operation

Secondary Outcomes (1)

• Change of alpha- and beta-diversity of fecal microbata

  Measured points: 4 weeks before surgery, on day of hospital admission and 8 weeks after surgery

Study Arms (2)

Trimodal 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: Trimodal rehabilitation + ERAS

ERAS + nutritional prehabilitation

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 + nutritional prehabilitation

Interventions

Trimodal rehabilitation + 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.

Also known as: Prehabilitation

Trimodal prehabilitation + ERAS

ERAS + nutritional prehabilitation PROCEDURE

Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation.

Also known as: Enhanced Recovery After Surgery

ERAS + nutritional prehabilitation

Eligibility Criteria

• Age: 18 Years - 80 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
• Biological Research Centre, Szeged: collaborator

Study Sites (2)

Department of Surgery, St. Borbala Hospital

Tatabánya, 2800, Hungary

Location

St. Borbala Hospital

Tatabánya, 2800, Hungary

Location

Related Publications (2)

• Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub3.

  PMID: 37162250 DERIVED

• Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.

  PMID: 35588252 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Preoperative Exercise; Enhanced Recovery After Surgery

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

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: 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: SPONSOR

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. 2:1 randomization will be performed for interventional and control arm

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 20, 2020
• Study Start: September 7, 2020
• Primary Completion: August 7, 2022
• Study Completion: June 7, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 10 years

Locations

HU (2)