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

NCT ID: NCT02531620

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-09-30

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.

Conditions

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Colorectal Cancer

Keywords

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prehabilitation colorectal surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Physiatry

Pre-operative Physiatry assessment and intervention

Group Type EXPERIMENTAL

Physiatry Assessment

Intervention Type OTHER

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.

Routine Care

Patients will receive routine pre-operative care, this study arm does not have an intervention.

Group Type OTHER

Routine Care

Intervention Type OTHER

Usual care for your disease process

Interventions

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Physiatry 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.

Intervention Type OTHER

Routine Care

Usual care for your disease process

Intervention Type OTHER

Other Intervention Names

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Standard Care

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nalin Amin, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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St Joseph Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Nalin Amin, MD

Role: CONTACT

Phone: 905 522-1155

Email: [email protected]

Susan Haley, BSc MSc

Role: CONTACT

Phone: 905 521-2100

Email: [email protected]

Facility Contacts

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Nalin Amin, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 28600373 (View on PubMed)

Other Identifiers

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2015A1

Identifier Type: -

Identifier Source: org_study_id