Pragmatic Prehabilitation for Colorectal Surgery

May 3, 2021 updated by: Chelsia Gillis, University of Calgary

Prehabilitation for Colorectal Surgery: A Pragmatic Effectiveness-Implementation Randomized Controlled Trial

Colorectal surgery is a common surgery for the treatment of colon and rectal cancers as well as other bowel diseases. Recovery from colorectal surgery is difficult because of the many potential negative side effects. These side effects include surgical complications, infections, and long hospital stays. It usually takes several months for patients to recover the strength required to return to their typical daily activities.

The Enhanced Recovery After Surgery program was established in Alberta in 2013 and uses several strategies to improve short-term patient recovery, including earlier discharge from hospital. Whether the ERAS program also improves long-term patient recovery, including quality of life and return to activities of daily living, is unclear. Whether the ERAS program would benefit from the addition of a prehabilitation element is unclear.

Prehabilitation programs are designed to use the waiting period before colorectal surgery to better prepare patients emotionally and physically for their operation. To date, successful prehabilitation programs have used a personalized care strategy where each patient is provided specific care instructions by healthcare professionals to meet their unique exercise, nutrition, and psychological needs. This prehabilitation strategy has been criticized for not being sustainable in our healthcare system.

A new prehabilitation program in response to this criticism is proposed. The prehabilitation program will be conducted in a more sustainable way by offering the program as a group class with a home-based component. ERAS patients at the Peter Lougheed Center are already offered a group class as part of the standard ERAS program. The prehabilitation class will be an extension of this group class that provides general nutrition, exercise, and anxiety-reduction/relaxation strategies to help patients prepare physically and emotionally for their operation. At this class, patients will learn to eat well, practice deep breathing exercises for relaxation, perform simple functional exercises, and to walk for exercise before their surgery. The surgical experience and outcomes of patients who received the additional prehabilitation care will be compared to those who received ERAS care only.

The overall goal of the study is to better understand how ERAS supports recovery after surgery and whether a prehabilitation program offers any additional benefits to the ERAS program currently in place.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
        • Peter Lougheed Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older;
  • elective colorectal surgery for primary disease under ERAS care at PLC;
  • have at least two weeks to participate before their scheduled surgery (i.e., surgery will NOT be rescheduled based on participation in this program);
  • are able to walk;
  • sufficient fluency in English to complete questionnaires.

Exclusion Criteria:

  • emergent surgery;
  • dairy allergy;
  • galactosemia;
  • strict vegans;

  • presence of a condition that could compromise the safety of the patient or adherence to the program, including

    • Co-morbid medical, physical, and/or mental conditions including dementia, disabling orthopedic and neuromuscular disease, psychosis;
    • Severe cardiopulmonary abnormalities, sepsis, and end-stage organ disease: cardiac failure (New York Heart Association classes III-IV), chronic obstructive pulmonary disease, renal failure (creatinine > 115µmol/l), hepatic failure (liver aminotranferases >50% the normal range).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prehab
General nutrition, relaxation, and exercise instructions. Home-based functional exercises, Fitbit goals, and nutrition supplements.
Combination product: Prehab
Exercise: functional exercises, walking, Fitbit goals Nutrition: handout, supplements (protein, vitamins, minerals) Stress reduction: deep breathing
Other: ERAS
Enhanced Recovery After Surgery guidelines are applied.
Behavioral: Fitbit
Fitbit is worn to monitor step counts.
Active Comparator: ERAS
Enhanced Recovery After Surgery standard of care plus Fitbit.
Other: ERAS
Enhanced Recovery After Surgery guidelines are applied.
Behavioral: Fitbit
Fitbit is worn to monitor step counts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay (LOS)
Time Frame: from date of surgery until hospital discharge, recorded in days, and assessed up to 6 weeks post-surgery
Length of hospital stay
from date of surgery until hospital discharge, recorded in days, and assessed up to 6 weeks post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: from date of surgery until 30 days post-surgery
Any complication within 30 days of surgery
from date of surgery until 30 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Chelsia Gillis, PhD(c), University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • REB18-0979

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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