Prehabilitation in Elective Colorectal Resection: A Pilot Study (Prehab)
Prehab
Prehabilitation Interventions in Elective Colorectal Resections: A Randomized Pilot Study (Prehab)
1 other identifier
interventional
70
1 country
1
Brief Summary
This is a pilot study designed to evaluate a programme of rehabilitation for patients undergoing elective colorectal resection surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2015
CompletedFirst Posted
Study publicly available on registry
August 24, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedNovember 23, 2016
November 1, 2016
2 years
August 19, 2015
November 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants recruiting
Screening and recruiting of eligible patients
6 months
Secondary Outcomes (10)
Post-op complications
30 days
Mortality
6 months
Length of Stay
30 days post-op
Number of patients with readmissions
30 days and 6 months
Physical Function Assessment (6 Minute Walk Test)
1, 3 and 6 months
- +5 more secondary outcomes
Study Arms (2)
Physiatry
EXPERIMENTALPre-operative Physiatry assessment and intervention
Routine Care
OTHERPatients will receive routine pre-operative care, this study arm does not have an intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- geographic inaccessibility
- unwilling to provide consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Joseph Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
Related Publications (1)
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.
PMID: 28600373DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nalin Amin, MD
McMaster University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2015
First Posted
August 24, 2015
Study Start
September 1, 2015
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
November 23, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share