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Trial record 82 of 318 for:    colon cancer | ( Map: Canada )

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

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Physiatry Assessment Other: Routine Care Not Applicable

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prehabilitation Interventions in Elective Colorectal Resections: A Randomized Pilot Study (Prehab)
Study Start Date : September 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: Physiatry
Pre-operative Physiatry assessment and intervention
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.

Routine Care
Patients will receive routine pre-operative care, this study arm does not have an intervention.
Other: Routine Care
Usual care for your disease process
Other Name: Standard Care




Primary Outcome Measures :
  1. Number of participants recruiting [ Time Frame: 6 months ]
    Screening and recruiting of eligible patients


Secondary Outcome Measures :
  1. 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

  2. Mortality [ Time Frame: 6 months ]
    Survival will be noted at completion of 6 month study period.

  3. Length of Stay [ Time Frame: 30 days post-op ]
    Length of stay in hospital will be collected and compared for the two treatment groups

  4. 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

  5. Physical Function Assessment (6 Minute Walk Test) [ Time Frame: 1, 3 and 6 months ]
    6 Minute Walk Test (6MWT)

  6. Symptom Assessment (Edmonton Symptom Assessment System) [ Time Frame: 1, 3 and 6 months ]
    Edmonton Symptom Assessment System (ESAS)

  7. 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)

  8. Quality of Life Survey (Short Form 36 Health Survey) [ Time Frame: 1, 3 and 6 months ]
    Short Form 36 Health Survey (SF-36)

  9. Pain Assessment (Visual Analog Scale) [ Time Frame: 1, 3 and 6 months ]
    Pain score by Visual Analog Scale

  10. Bowel Function Assessment [ Time Frame: 1, 3 and 6 months ]
    Bowel Function Index



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531620


Contacts
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Contact: Nalin Amin, MD 905 522-1155 ext 32938 amin@mcmaster.ca
Contact: Susan Haley, BSc MSc 905 521-2100 ext 32575 haleys@mcmaster.ca

Locations
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Canada, Ontario
St Joseph Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Nalin Amin, MD    905.522.1155 ext 37320      
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Nalin Amin, MD McMaster University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02531620     History of Changes
Other Study ID Numbers: 2015A1
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by McMaster University:
prehabilitation
colorectal surgery
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases