Clinical trial NCT02531620: Prehabilitation in Elective Colorectal Resection: A Pilot Study (Prehab)
Official title: Prehabilitation Interventions in Elective Colorectal Resections: A Randomized Pilot Study (Prehab)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: prehabilitation
colorectal surgery
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2015-08-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants recruiting
timeFrame: 6 months
Secondary outcomes:
measure: Post-op complications
timeFrame: 30 days
measure: Mortality
timeFrame: 6 months
measure: Length of Stay
timeFrame: 30 days post-op
measure: Number of patients with readmissions
timeFrame: 30 days and 6 months
measure: Physical Function Assessment (6 Minute Walk Test)
timeFrame: 1, 3 and 6 months
measure: Symptom Assessment (Edmonton Symptom Assessment System)
timeFrame: 1, 3 and 6 months
measure: Functional Independence Assessment (UK Functional Independence Measure and Functional Assessment Measure)
timeFrame: 1, 3 and 6 months
measure: Quality of Life Survey (Short Form 36 Health Survey)
timeFrame: 1, 3 and 6 months
measure: Pain Assessment (Visual Analog Scale)
timeFrame: 1, 3 and 6 months
measure: Bowel Function Assessment
timeFrame: 1, 3 and 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St Joseph Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Nalin Amin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong SG, Maida E, Harvey D, Wagner N, Sonnadara R, Amin N. Evaluation of a physiatrist-directed prehabilitation intervention in frail patients with colorectal cancer: a randomised pilot study protocol. BMJ Open. 2017 Jun 9;7(6):e015565. doi: 10.1136/bmjopen-2016-015565.