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

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

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

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Physiatry Assessment; Other: Routine Care

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: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • Recruiting
      • St Joseph Healthcare Hamilton
      • Contact: Nalin Amin, MD; Phone Number: 37320 905.522.1155

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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 Names: Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants recruiting	Screening and recruiting of eligible patients	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mortality	Survival will be noted at completion of 6 month study period.	6 months
Length of Stay	Length of stay in hospital will be collected and compared for the two treatment groups	30 days post-op
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
Physical Function Assessment (6 Minute Walk Test)	6 Minute Walk Test (6MWT)	1, 3 and 6 months
Symptom Assessment (Edmonton Symptom Assessment System)	Edmonton Symptom Assessment System (ESAS)	1, 3 and 6 months
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
Quality of Life Survey (Short Form 36 Health Survey)	Short Form 36 Health Survey (SF-36)	1, 3 and 6 months
Pain Assessment (Visual Analog Scale)	Pain score by Visual Analog Scale	1, 3 and 6 months
Bowel Function Assessment	Bowel Function Index	1, 3 and 6 months

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Nalin Amin, MD, McMaster University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: August 19, 2015
• First Submitted That Met QC Criteria: August 21, 2015
• First Posted (Estimate): August 24, 2015

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: November 22, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: colorectal surgery; prehabilitation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2015A1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No