Prehabilitation - Enhanced Recovery After Colorectal Surgery

Not Applicable

Completed

• Conditions: Surgical Operation With Reversal of External Stoma; Colorectal Surgery
• Interventions: Other: Reference; Other: Cardiorespiratory and resistance training.

• Registration Number: NCT02746731
• Lead Sponsor: Kantonsspital Winterthur KSW

Brief Summary

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-21
• Study Start: 2016-06
• Status Verified: 2019-03
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference	Reference	Usual care.
Prehabilitation	Cardiorespiratory and resistance training.	'Cardiorespiratory and resistance training.

Primary Outcome Measures

Name	Time	Method
Comprehensive Complication Index (CCI)	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 Outcome Measures

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

Trial Locations

Locations (1)

Kantonsspital Winterthur; 🇨🇭 Winterthur, Zurich, Switzerland