CClinicalTrials.gg
Status unknownNCT02531620PrehabUpdated Nov 23, 2016

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

An interventional study of Physiatry Assessment and Routine Care in Colorectal Cancer, sponsored by McMaster University. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-23.

Sponsored by McMaster University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Colorectal Cancer

Keywords

  • prehabilitation
  • colorectal surgery
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 70 is close to the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • geographic inaccessibility
  • unwilling to provide consent
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Physiatry

    Pre-operative Physiatry assessment and intervention

    Other: Physiatry Assessment

  • Other
    Routine Care

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

    Other: Routine Care

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

    Also known as: Standard Care

06

What researchers measure

Primary outcomes

  1. Number of participants recruiting

    Screening and recruiting of eligible patients

    Time frame: 6 months

Secondary outcomes

  1. Post-op complications

    Post-op complications by Clavien-Dindo classification (pulmonary, DVT, MI) Completed by surgical team during admission, discharge and 30 days

    Time frame: 30 days

  2. Mortality

    Survival will be noted at completion of 6 month study period.

    Time frame: 6 months

  3. Length of Stay

    Length of stay in hospital will be collected and compared for the two treatment groups

    Time frame: 30 days post-op

  4. 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

    Time frame: 30 days and 6 months

  5. Physical Function Assessment (6 Minute Walk Test)

    6 Minute Walk Test (6MWT)

    Time frame: 1, 3 and 6 months

  6. Symptom Assessment (Edmonton Symptom Assessment System)

    Edmonton Symptom Assessment System (ESAS)

    Time frame: 1, 3 and 6 months

  7. Functional Independence Assessment (UK Functional Independence Measure and Functional Assessment Measure)

    UK Functional Independence Measure and Functional Assessment Measure (UK FIM+FAM)

    Time frame: 1, 3 and 6 months

  8. Quality of Life Survey (Short Form 36 Health Survey)

    Short Form 36 Health Survey (SF-36)

    Time frame: 1, 3 and 6 months

  9. Pain Assessment (Visual Analog Scale)

    Pain score by Visual Analog Scale

    Time frame: 1, 3 and 6 months

  10. Bowel Function Assessment

    Bowel Function Index

    Time frame: 1, 3 and 6 months

07

Study locations

1 of 1 sites recruiting
  • St Joseph Healthcare Hamilton
    Hamilton, Ontario L8N 4A6, Canada
    • Nalin Amin, MD · Contact · 905.522.1155
    Recruiting
08

References and documents

Publications

  • 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. PubMed 28600373 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02531620
Lead sponsor
McMaster University
Responsible party
Sponsor
First posted
Aug 24, 2015
Start date
Sep 2015
Primary completion
Sep 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Nov 23, 2016

Study contacts

Nalin Amin, MD
Contact
amin@mcmaster.ca
905 522-1155 ext. 32938
Susan Haley, BSc MSc
Contact
haleys@mcmaster.ca
905 521-2100 ext. 32575
Nalin Amin, MD
principal investigator · McMaster University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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