Prehabilitation - Enhanced Recovery After Colorectal Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02746731
• Date of registration: 18/04/2016
• Prospective Registration: Yes
• Primary sponsor: Kantonsspital Winterthur KSW
• Public title: Prehabilitation - Enhanced Recovery After Colorectal Surgery pERACS
• Scientific 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
• Date of first enrolment: June 2016
• Target sample size: 112
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02746731
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Stefan Breitenstein, MD, PD
• Affiliation: Kantonsspital Winterthur KSW

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colorectal Surgery

Surgical Operation With Reversal of External Stoma

Intervention(s)

Other: Cardiorespiratory and resistance training.

Other: Reference

Primary Outcome(s)

Comprehensive Complication Index (CCI) [Time Frame: 30 days]

Secondary Outcome(s)

Five Times Sit to Stand Test [Time Frame: 30 days]

Perceived pain [Time Frame: 30 days]

2-Minute Walk Test [Time Frame: 30 days]

Clavien/Dindo [Time Frame: 30 days]

Secondary ID(s)

pERACS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Zurich

Zurich University of Applied Sciences