Pragmatic Prehabilitation for Colorectal Surgery

NCT04247776 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-05-05

No results posted yet for this study

Summary

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.

Conditions

  • Prehabilitation
  • Colorectal Surgery
  • Enhanced Recovery After Surgery

Interventions

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.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Chelsia Gillis, PhD(c) · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2020-09-01
Completion
2021-05-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04247776 on ClinicalTrials.gov