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NCT02746731

Prehabilitation - Enhanced Recovery After Colorectal Surgery

Datenbasis: BASEC (Import vom 28.03.2024), WHO (Import vom 20.03.2024)
Geändert: 20.12.2020, 01:04
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

Surgical Operation With Reversal of External Stoma;Colorectal Surgery

Interventions (Datenquelle: WHO)

Other: Cardiorespiratory and resistance training.;Other: Reference

Inclusion/Exclusion Criteria (Datenquelle: 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

Weitere Angaben zur Studie im WHO-Primärregister

https://clinicaltrials.gov/show/NCT02746731

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02746731
Weitere Informationen zur Studie

Datum der Studienregistrierung

18.04.2016

Einschluss der ersten teilnehmenden Person

01.06.2016

Rekrutierungsstatus

Completed

Wissenschaftlicher Titel (Datenquelle: 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

Studientyp (Datenquelle: WHO)

Interventional

Design der Studie (Datenquelle: WHO)

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

Phase (Datenquelle: WHO)

N/A

Primäre Endpunkte (Datenquelle: WHO)

Comprehensive Complication Index (CCI)

Sekundäre Endpunkte (Datenquelle: WHO)

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

Kontakt für Auskünfte (Datenquelle: WHO)

Please refer to primary and secondary sponsors

Ergebnisse der Studie (Datenquelle: WHO)

Zusammenfassung der Ergebnisse

noch keine Angaben verfügbar

Link zu den Ergebnissen im Primärregister

noch keine Angaben verfügbar

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten

No

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

Switzerland

Kontakt für weitere Auskünfte zur Studie

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Stefan Breitenstein, MD, PD
Kantonsspital Winterthur KSW

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Stefan Breitenstein, MD, PD
Kantonsspital Winterthur KSW

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

pERACS
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