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Completed

NCT Number: NCT02746731

Prehabilitation - Enhanced Recovery After Colorectal Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiorespiratory and resistance training.

Other

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.

reference

Other

No preoperative physical therapy training. Patients will be informed to remain physically active (as usual) until surgery.

Other names: Usual care.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. Five Times Sit to Stand Test

    Time frame: 30 days

    Time needed to raise from and sit-down on a chair for five times.

  3. 2-Minute Walk Test

    Time frame: 30 days

    Distance covered within two minutes of brisk walking.

  4. Perceived pain

    Time frame: 30 days

    Numeric rating scale ranging from Zero (no pain) to ten (worst pain).

Other outcomes

  1. 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.

  2. hand grip strength

    Time frame: 30 days

    Jamar handheld dynamometer.

  3. Rating of Perceived Exertion

    Time frame: 30 days

    Borg scale.

  4. Steep ramp test

    Time frame: 30 days

    Test to determine training intensity.

  5. Modified Iowa Levels of Assistance Scale (Milas)

    Time frame: 30 days

    Measure to quantify the gait and mobility impairments

Sponsors and collaborators

Lead sponsor

Kantonsspital Winterthur KSW

Other

Collaborators

  • University of Zurich
  • Zurich University of Applied Sciences

Registry information

Official study title

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

Acronym: pERACS

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 21, 2016
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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