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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02531620
Acronym
Prehab
Enrollment
70
Registered
2015-08-24
Start date
2015-09-30
Completion date
2017-09-30
Last updated
2016-11-23

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

Conditions

Colorectal Cancer

Keywords

prehabilitation, colorectal surgery

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.

Interventions

OTHERPhysiatry Assessment

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.

OTHERRoutine Care

Usual care for your disease process

Sponsors

McMaster University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants recruiting6 monthsScreening and recruiting of eligible patients

Secondary

MeasureTime frameDescription
Mortality6 monthsSurvival will be noted at completion of 6 month study period.
Length of Stay30 days post-opLength of stay in hospital will be collected and compared for the two treatment groups
Number of patients with readmissions30 days and 6 monthsNumber of patients with readmission to hospital during the 30 day and 6 month period will be compared for the two treatment groups
Physical Function Assessment (6 Minute Walk Test)1, 3 and 6 months6 Minute Walk Test (6MWT)
Post-op complications30 daysPost-op complications by Clavien-Dindo classification (pulmonary, DVT, MI) Completed by surgical team during admission, discharge and 30 days
Functional Independence Assessment (UK Functional Independence Measure and Functional Assessment Measure)1, 3 and 6 monthsUK Functional Independence Measure and Functional Assessment Measure (UK FIM+FAM)
Quality of Life Survey (Short Form 36 Health Survey)1, 3 and 6 monthsShort Form 36 Health Survey (SF-36)
Pain Assessment (Visual Analog Scale)1, 3 and 6 monthsPain score by Visual Analog Scale
Bowel Function Assessment1, 3 and 6 monthsBowel Function Index
Symptom Assessment (Edmonton Symptom Assessment System)1, 3 and 6 monthsEdmonton Symptom Assessment System (ESAS)

Countries

Canada

Contacts

Primary ContactNalin Amin, MD
amin@mcmaster.ca905 522-1155
Backup ContactSusan Haley, BSc MSc
haleys@mcmaster.ca905 521-2100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026