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NCT02746731

Prehabilitation - Enhanced Recovery After Colorectal Surgery

Data source: BASEC (Imported from 26.04.2024), WHO (Imported from 25.04.2024)
Changed: Dec 20, 2020, 1:04 AM
Disease category:

Health conditions (Data source: WHO)

Surgical Operation With Reversal of External Stoma;Colorectal Surgery

Interventions (Data source: WHO)

Other: Cardiorespiratory and resistance training.;Other: Reference

Inclusion/Exclusion Criteria (Data source: WHO)


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

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT02746731

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02746731
Further information on trial

Date trial registered

Apr 18, 2016

Incorporation of the first participant

Jun 1, 2016

Recruitment status

Completed

Academic title (Data source: WHO)

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

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).

Phase (Data source: WHO)

N/A

Primary end point (Data source: WHO)

Comprehensive Complication Index (CCI)

Secundary end point (Data source: WHO)

Perceived pain;2-Minute Walk Test;Five Times Sit to Stand Test;Clavien/Dindo

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

No

Trial sites

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Contact for general information (Data source: WHO)

Stefan Breitenstein, MD, PD
Kantonsspital Winterthur KSW

Contact for scientific information (Data source: WHO)

Stefan Breitenstein, MD, PD
Kantonsspital Winterthur KSW

Further trial identification numbers

Secondary ID (Data source: WHO)

pERACS
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