Randomized Controlled Trial Assessing the Value of Prehabilitation in Patients Undergoing Colorectal Surgery According to the ERAS Protocol for the Improvement of Postoperative Outcomes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Surgical Operation With Reversal of External Stoma
- Sponsor
- Kantonsspital Winterthur KSW
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Comprehensive Complication Index (CCI)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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
- Five Times Sit to Stand Test(30 days)
- 2-Minute Walk Test(30 days)
- Perceived pain(30 days)
- Clavien/Dindo(30 days)