NCT02746731

Prehabilitation - Enhanced Recovery After Colorectal Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Kantonsspital Winterthur KSW · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Operation With Reversal of External Stoma
• Colorectal Surgery

Interventions

Type	Name	Description
OTHER	Cardiorespiratory and resistance training.	A cardiorespiratory and resistance training program for at least 2 to 3 weeks will be conducted 3-times per week, of which two sessions will be supervised by a qualified person of the institute of physiotherapy and one session will be unsupervised and home-based. Physiotherapy consists of one hour, moderate to intense interval training combined with muscle strength training.
OTHER	Reference	No preoperative physical therapy training. Patients will be informed to remain physically active (as usual) until surgery.

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2016-04-21
• Last updated: 2019-03-22

Locations

1 site across 1 country: Switzerland