Observing the Perioperative Effects of Prehabilitation in Colorectal Cancer Patients

February 17, 2021 updated by: Richard Dickson-Lowe, Medway Primary Care Trust

Observing the Perioperative Effects of Prehabilitation in Colorectal Cancer

Quality Improvement Project to evaluate how prehabilitation can be incorporated into our colorectal cancer pathway and assess its clinical benefits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim was to evaluate how prehabilitation (PH) can be incorporated into our colorectal cancer pathway and assess its clinical benefits.

Patients underwent PH (exercise, nutrition and psychological support) before resection of colorectal carcinoma in a DGH over fourteen months. Patients were matched by operation, age, sex and ASA to non-prehabilitation (NPH) patients using a prospectively maintained database. Length of stay (LoS) and complication rate and 90-day readmission rates were compared using Wilcoxon and McNemar's methods.

Prehabilitation significantly improved peak VO2 and AT. This corresponds to a reduction in predicted 30-day mortality. Despite a higher Charlson index LoS was unchanged suggesting prehabilitation may permit safe resection in comorbid patients.

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kent
      • Gillingham, Kent, United Kingdom, ME7 5NY
        • Medway Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients over the age of 18 needing surgery were identified from clinics, endoscopy or weekly multidisciplinary meetings (MDT). Patients who were clinically judged to be frail or had multiple comorbidities were referred for prehabilitation prior to resection. Those that underwent prehabilitation were matched using operation type, age, sex and ASA with patients who did not have prehabilitation prior to resection. Surgery for all patients was carried out within the context of an enhanced recovery programme.

Description

Inclusion Criteria:

  • Adults over the age of 18 who had prehabilitation for colorectal cancer

Exclusion Criteria:

  • Children
  • Patients who had prehabilitation but not for colorectal cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prehabilitation (PH)
Patients who underwent prehabilitation prior to colorectal cancer resection
Prehabilitation is a multimodal and multidisciplinary person-centred perioperative approach involving supervised exercise training, nutritional education, management of polypharmacy and psychological advice.
Non-Prehabilitation (NPH)
Patients who did not undergo prehabilitation prior to colorectal cancer resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: From date of operation to date of discharge in number of days over a 90 day follow up period
Time spent in hospital
From date of operation to date of discharge in number of days over a 90 day follow up period
Complication rate
Time Frame: Follow up over a period of 90 days following operation
All Clavien-Dindo complications
Follow up over a period of 90 days following operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anaerobic threshold
Time Frame: CPET performed before prehabilitation and after prehabilitation (median of 36 days)
Measured by looking at CPET results pre- and post- prehab
CPET performed before prehabilitation and after prehabilitation (median of 36 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Richard A Dickson-Lowe, Medway PCT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

January 22, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (ACTUAL)

February 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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