Prehabilitation - Enhanced Recovery After Colorectal Surgery

Colorectal Surgery Clinical Trial

— pERACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02746731
• Other study ID #: pERACS
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Kantonsspital Winterthur KSW
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Surgery
• Surgical Operation With Reversal of External Stoma

Intervention

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.
• Reference
No preoperative physical therapy training. Patients will be informed to remain physically active (as usual) until surgery.

Locations

Country	Name	City	State
Switzerland	Kantonsspital Winterthur	Winterthur	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
Kantonsspital Winterthur KSW	University of Zurich, Zurich University of Applied Sciences

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Bardram L, Funch-Jensen P, Jensen P, Crawford ME, Kehlet H. Recovery after laparoscopic colonic surgery with epidural analgesia, and early oral nutrition and mobilisation. Lancet. 1995 Mar 25;345(8952):763-4. — View Citation

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. — View Citation

Dronkers JJ, Chorus AM, van Meeteren NL, Hopman-Rock M. The association of pre-operative physical fitness and physical activity with outcome after scheduled major abdominal surgery. Anaesthesia. 2013 Jan;68(1):67-73. doi: 10.1111/anae.12066. Epub 2012 Nov 5. — View Citation

Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(®)) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. — View Citation

Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The self-reported International Physical Activity Questionnaire short-form (IPAQ-SF)	The IPAQ is used as a comparable and standardised self-report measure of habitual physical activity.	30 days
Other	hand grip strength	Jamar handheld dynamometer.	30 days
Other	Rating of Perceived Exertion	Borg scale.	30 days
Other	Steep ramp test	Test to determine training intensity.	30 days
Other	Modified Iowa Levels of Assistance Scale (Milas)	Measure to quantify the gait and mobility impairments	30 days
Primary	Comprehensive Complication Index (CCI)	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).	30 days
Secondary	Clavien/Dindo	Assessment of post-surgical complications, ranging from Grade I (any deviation from normal postoperative Course) to Grade V (death of Patient).	30 days
Secondary	Five Times Sit to Stand Test	Time needed to raise from and sit-down on a chair for five times.	30 days
Secondary	2-Minute Walk Test	Distance covered within two minutes of brisk walking.	30 days
Secondary	Perceived pain	Numeric rating scale ranging from Zero (no pain) to ten (worst pain).	30 days