Prehabilitation - Enhanced Recovery After Colorectal Surgery (pERACS)

March 21, 2019 updated by: Kantonsspital Winterthur KSW

Randomized Controlled Trial Assessing the Value of Prehabilitation in Patients Undergoing Colorectal Surgery According to the ERAS Protocol for the Improvement of Postoperative Outcomes

The purpose of this study is to determine whether a combined cardiorespiratory and strengthening training prior to colorectal surgery decreases the rate of surgery-related complications.

Study Overview

Detailed Description

This single site study investigates whether a preoperative training reduces the number and severity of perioperative complications in patients undergoing elective colorectal surgery according to the Enhanced Recovery After Surgery (ERAS) pathway.

The study will be approved by a local ethical committee and conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the ICH-GCP as well as all national legal and regulatory requirements. Before inclusion informed written consent will be obtained from all patients.

Once the indication for the surgical intervention is given patients may be included into the study. Patients of the experimental group will be provided with a tailored training program aiming at maximally improving physical fitness in order to withstand the surgical stress. Depending on the urgency of the operation this training program will last between two and six weeks. Three weekly trainings are foreseen of which two will be performed in a setting supervised by a physiotherapist and one at the patient's home.

Patients assigned to the control group receive the usual care i.e. information about the upcoming procedure and the advice to remain physically active.

From the point of the operation both groups will be treated equally. Outcome measures will be obtained from the inclusion into the study up to one month after surgery.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

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

    • Zurich
      • Winterthur, Zurich, Switzerland, 8401
        • Kantonsspital Winterthur

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

Description

Inclusion Criteria:

  • Adult patients (age ≥ 18 years) suffering from colorectal diseases needing an operative treatment and treated along our ERAS pathway
  • Patients suffering from colorectal cancer, diverticulosis, benign tumors such as polyps or inflammatory bowel disease and surgically treated (i.e. rectosigmoid resection, anterior resection of rectum, ileocaecal/right hemicolectomy, left hemicolectomy, abdominoperineal resection or total/subtotal colectomy), and patients undergoing reversal of Stoma and Hartmann procedures will be included.
  • Informed Consent as documented by signature

Exclusion Criteria:

  • Patients suffering from severe dementia or other cognitive impairment, what hinders them to give informed consent
  • Patients with a physical impairment, who can't perform the necessary physical Training
  • Patients, who are not able or willing to attend the physical training at the institute of physiotherapy of the Kantonsspital Winterthur
  • Inability of the participant to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc.
  • Participation in another study with investigational drug within the 30 days preceding and during the present study
  • Enrolment of the investigator, his/her family members, employees and other dependent persons

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prehabilitation
'Cardiorespiratory and resistance training.

A cardiorespiratory and resistance training program for at least 2 to 3 weeks will be conducted 3-times per week, of which two sessions will be supervised by a qualified person of the institute of physiotherapy and one session will be unsupervised and home-based.

Physiotherapy consists of one hour, moderate to intense interval training combined with muscle strength training.

Active Comparator: Reference
Usual care.
No preoperative physical therapy training. Patients will be informed to remain physically active (as usual) until surgery.
Other Names:
  • Usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comprehensive Complication Index (CCI)
Time Frame: 30 days
ssessment of patients' overall morbidity. CCI is based on the complication grading by Clavien-Dindo Classification and implements every occurred complication after an intervention. The overall morbidity is reflected on a scale from 0 (no complication) to 100 (death).
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clavien/Dindo
Time Frame: 30 days
Assessment of post-surgical complications, ranging from Grade I (any deviation from normal postoperative Course) to Grade V (death of Patient).
30 days
Five Times Sit to Stand Test
Time Frame: 30 days
Time needed to raise from and sit-down on a chair for five times.
30 days
2-Minute Walk Test
Time Frame: 30 days
Distance covered within two minutes of brisk walking.
30 days
Perceived pain
Time Frame: 30 days
Numeric rating scale ranging from Zero (no pain) to ten (worst pain).
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The self-reported International Physical Activity Questionnaire short-form (IPAQ-SF)
Time Frame: 30 days
The IPAQ is used as a comparable and standardised self-report measure of habitual physical activity.
30 days
hand grip strength
Time Frame: 30 days
Jamar handheld dynamometer.
30 days
Rating of Perceived Exertion
Time Frame: 30 days
Borg scale.
30 days
Steep ramp test
Time Frame: 30 days
Test to determine training intensity.
30 days
Modified Iowa Levels of Assistance Scale (Milas)
Time Frame: 30 days
Measure to quantify the gait and mobility impairments
30 days

Collaborators and Investigators

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

Investigators

  • Study Chair: Stefan Breitenstein, MD, PD, Kantonsspital Winterthur KSW

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2016

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimate)

April 21, 2016

Study Record Updates

Last Update Posted (Actual)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 21, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • pERACS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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