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Pragmatic Prehabilitation for Colorectal Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04247776
Enrollment
110
Registered
2020-01-30
Start date
2018-12-01
Completion date
2021-05-01
Last updated
2021-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Surgery, Enhanced Recovery After Surgery, Prehabilitation

Brief 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.

Interventions

COMBINATION_PRODUCTPrehab

Exercise: functional exercises, walking, Fitbit goals Nutrition: handout, supplements (protein, vitamins, minerals) Stress reduction: deep breathing

OTHERERAS

Enhanced Recovery After Surgery guidelines are applied.

BEHAVIORALFitbit

Fitbit is worn to monitor step counts.

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Pragmatic RCT Effectiveness- Implementation Hybrid

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Length of stay (LOS)from date of surgery until hospital discharge, recorded in days, and assessed up to 6 weeks post-surgeryLength of hospital stay

Secondary

MeasureTime frameDescription
Complicationsfrom date of surgery until 30 days post-surgeryAny complication within 30 days of surgery

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026