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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02531620
Recruitment Status : Unknown
Verified November 2016 by McMaster University.
Recruitment status was:  Recruiting
First Posted : August 24, 2015
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date  ICMJE August 19, 2015
First Posted Date  ICMJE August 24, 2015
Last Update Posted Date November 23, 2016
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2015)
Number of participants recruiting [ Time Frame: 6 months ]
Screening and recruiting of eligible patients
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2015)
  • Post-op complications [ Time Frame: 30 days ]
    Post-op complications by Clavien-Dindo classification (pulmonary, DVT, MI) Completed by surgical team during admission, discharge and 30 days
  • Mortality [ Time Frame: 6 months ]
    Survival will be noted at completion of 6 month study period.
  • Length of Stay [ Time Frame: 30 days post-op ]
    Length of stay in hospital will be collected and compared for the two treatment groups
  • Number of patients with readmissions [ Time Frame: 30 days and 6 months ]
    Number 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) [ Time Frame: 1, 3 and 6 months ]
    6 Minute Walk Test (6MWT)
  • Symptom Assessment (Edmonton Symptom Assessment System) [ Time Frame: 1, 3 and 6 months ]
    Edmonton Symptom Assessment System (ESAS)
  • Functional Independence Assessment (UK Functional Independence Measure and Functional Assessment Measure) [ Time Frame: 1, 3 and 6 months ]
    UK Functional Independence Measure and Functional Assessment Measure (UK FIM+FAM)
  • Quality of Life Survey (Short Form 36 Health Survey) [ Time Frame: 1, 3 and 6 months ]
    Short Form 36 Health Survey (SF-36)
  • Pain Assessment (Visual Analog Scale) [ Time Frame: 1, 3 and 6 months ]
    Pain score by Visual Analog Scale
  • Bowel Function Assessment [ Time Frame: 1, 3 and 6 months ]
    Bowel Function Index
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prehabilitation in Elective Colorectal Resection: A Pilot Study (Prehab)
Official Title  ICMJE Prehabilitation Interventions in Elective Colorectal Resections: A Randomized Pilot Study (Prehab)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Other: 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.
  • Other: Routine Care
    Usual care for your disease process
    Other Name: Standard Care
Study Arms  ICMJE
  • Experimental: Physiatry
    Pre-operative Physiatry assessment and intervention
    Intervention: Other: Physiatry Assessment
  • Routine Care
    Patients will receive routine pre-operative care, this study arm does not have an intervention.
    Intervention: Other: Routine Care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 21, 2015)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2017
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02531620
Other Study ID Numbers  ICMJE 2015A1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nalin Amin, MD McMaster University
PRS Account McMaster University
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP