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

Colorectal Cancer Clinical Trial

— Prehab  

Official title:

Prehabilitation Interventions in Elective Colorectal Resections: A Randomized Pilot Study (Prehab)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02531620
• Other study ID #: 2015A1
• Status: Recruiting
• Phase: N/A
• First received: August 19, 2015
• Last updated: November 22, 2016
• Start date: September 2015
• Est. completion date: September 2017

Study information

• Verified date: November 2016
• Source: McMaster University
• Contact: Nalin Amin, MD
• Phone: 905 522-1155
• Email: amin[@]mcmaster.ca
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

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
Usual care for your disease process

Locations

Country	Name	City	State
Canada	St Joseph Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants recruiting	Screening and recruiting of eligible patients	6 months	No
Secondary	Post-op complications	Post-op complications by Clavien-Dindo classification (pulmonary, DVT, MI) Completed by surgical team during admission, discharge and 30 days	30 days	No
Secondary	Mortality	Survival will be noted at completion of 6 month study period.	6 months	No
Secondary	Length of Stay	Length of stay in hospital will be collected and compared for the two treatment groups	30 days post-op	No
Secondary	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	30 days and 6 months	No
Secondary	Physical Function Assessment (6 Minute Walk Test)	6 Minute Walk Test (6MWT)	1, 3 and 6 months	No
Secondary	Symptom Assessment (Edmonton Symptom Assessment System)	Edmonton Symptom Assessment System (ESAS)	1, 3 and 6 months	No
Secondary	Functional Independence Assessment (UK Functional Independence Measure and Functional Assessment Measure)	UK Functional Independence Measure and Functional Assessment Measure (UK FIM+FAM)	1, 3 and 6 months	No
Secondary	Quality of Life Survey (Short Form 36 Health Survey)	Short Form 36 Health Survey (SF-36)	1, 3 and 6 months	No
Secondary	Pain Assessment (Visual Analog Scale)	Pain score by Visual Analog Scale	1, 3 and 6 months	No
Secondary	Bowel Function Assessment	Bowel Function Index	1, 3 and 6 months	No