Prehabilitation in Elective Colorectal Resection: A Pilot Study (Prehab)

Study Overview
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Brief Summary
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This is a pilot study designed to evaluate a programme of rehabilitation for patients undergoing elective colorectal resection surgery.

Detailed Description
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Operations on the colon and rectum are major abdominal operations and many individuals can become severely deconditioned or weakened afterwards. For some individuals this can even mean that they can no longer completely return to their usual way of life following one of these major operations. As part of this study the investigators are attempting to identify ways to maximize patients' recovery and to maximize their overall quality of life following these major operations. It is possible that preconditioning may make a difference to patient's overall quality of life, decreased or need for hospital length of stay and decreased postoperative medical complications occasionally seen during these operations, in essence provide an overall enhancement to their surgical recovery. Physiatrists are physicians who are medical experts in maximizing a patient's overall ability to function well and live independently. Investigators are proposing patient participation in an initial pilot study in order to test the question as to whether or not participation with a physiatrist and any interventions recommended by said physician would help improve a patient's postoperative recovery.

Official Title
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Prehabilitation Interventions in Elective Colorectal Resections: A Randomized Pilot Study (Prehab)

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Physiatry Assessment
* Other: Routine Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patient scheduled to undergo a colorectal resection as part of treatment for colorectal cancer. English speaking or have available a family member or substitute decision maker who can accompany you to all of your study visits. Exclusion Criteria: geographic inaccessibility unwilling to provide consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiatry<br>Pre-operative Physiatry assessment and intervention | Other: Physiatry Assessment<br>* Physiatrists are physicians who are medical experts in maximizing a patient's overall ability to function well and live independently. The Investigators are proposing your participation in an initial pilot study in order to test the question as to whether or not participation with a physiatrist and any interventions recommended by said physician would help improve a patient's postoperative recovery.<br>|
| Other: Routine Care<br>Patients will receive routine pre-operative care, this study arm does not have an intervention. | Other: Routine Care<br>* Usual care for your disease process<br>* Other names: Standard Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants recruiting | Screening and recruiting of eligible patients | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-op complications | Post-op complications by Clavien-Dindo classification (pulmonary, DVT, MI) Completed by surgical team during admission, discharge and 30 days | 30 days | 
| Mortality | Survival will be noted at completion of 6 month study period. | 6 months | 
| Length of Stay | Length of stay in hospital will be collected and compared for the two treatment groups | 30 days post-op | 
| Number of patients with readmissions | Number of patients with readmission to hospital during the 30 day and 6 month period will be compared for the two treatment groups | 30 days and 6 months | 
| Physical Function Assessment (6 Minute Walk Test) | 6 Minute Walk Test (6MWT) | 1, 3 and 6 months | 
| Symptom Assessment (Edmonton Symptom Assessment System) | Edmonton Symptom Assessment System (ESAS) | 1, 3 and 6 months | 
| Functional Independence Assessment (UK Functional Independence Measure and Functional Assessment Measure) | UK Functional Independence Measure and Functional Assessment Measure (UK FIM+FAM) | 1, 3 and 6 months | 
| Quality of Life Survey (Short Form 36 Health Survey) | Short Form 36 Health Survey (SF-36) | 1, 3 and 6 months | 
| Pain Assessment (Visual Analog Scale) | Pain score by Visual Analog Scale | 1, 3 and 6 months | 
| Bowel Function Assessment | Bowel Function Index | 1, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prehabilitation, colorectal surgery