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Completed

NCT Number: NCT04247776

Pragmatic Prehabilitation for Colorectal Surgery

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.

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Key information

Conditions

Prehabilitation Colorectal Surgery Enhanced Recovery After Surgery

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peter Lougheed Center

Calgary, Alberta, T1Y 6J4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Prehab

Combination Product

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

ERAS

Other

Enhanced Recovery After Surgery guidelines are applied.

Fitbit

Behavioral

Fitbit is worn to monitor step counts.

Primary outcomes

  1. 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

Secondary outcomes

  1. Complications

    Time frame: from date of surgery until 30 days post-surgery

    Any complication within 30 days of surgery

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jan 30, 2020
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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