Clinical trial NCT02746731: Prehabilitation - Enhanced Recovery After Colorectal Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Operation With Reversal of External Stoma
Colorectal Surgery
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
Collaborators: name: University of Zurich
name: Zurich University of Applied Sciences
First posted: 2016-04-21
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Comprehensive Complication Index (CCI)
timeFrame: 30 days
Secondary outcomes:
measure: Clavien/Dindo
timeFrame: 30 days
measure: Five Times Sit to Stand Test
timeFrame: 30 days
measure: 2-Minute Walk Test
timeFrame: 30 days
measure: Perceived pain
timeFrame: 30 days
Other outcomes:
measure: The self-reported International Physical Activity Questionnaire short-form (IPAQ-SF)
timeFrame: 30 days
measure: hand grip strength
timeFrame: 30 days
measure: Rating of Perceived Exertion
timeFrame: 30 days
measure: Steep ramp test
timeFrame: 30 days
measure: Modified Iowa Levels of Assistance Scale (Milas)
timeFrame: 30 days
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zurich
Study officials:
affiliation: Kantonsspital Winterthur KSW
name: Stefan Breitenstein, MD, PD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1016/s0140-6736(95)90643-6.
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. doi: 10.1097/01.sla.0000133083.54934.ae.
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.
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.
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((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.
citation: Gloor S, Misirlic M, Frei-Lanter C, Herzog P, Muller P, Schafli-Thurnherr J, Lamdark T, Schregel D, Wyss R, Unger I, Gisi D, Greco N, Mungo G, Wirz M, Raptis DA, Tschuor C, Breitenstein S. Prehabilitation in patients undergoing colorectal surgery fails to confer reduction in overall morbidity: results of a single-center, blinded, randomized controlled trial. Langenbecks Arch Surg. 2022 May;407(3):897-907. doi: 10.1007/s00423-022-02449-0. Epub 2022 Jan 27.
citation: Taha A, Taha-Mehlitz S, Staartjes VE, Lunger F, Gloor S, Unger I, Mungo G, Tschuor C, Breitenstein S, Gingert C. Association of a prehabilitation program with anxiety and depression before colorectal surgery: a post hoc analysis of the pERACS randomized controlled trial. Langenbecks Arch Surg. 2021 Aug;406(5):1553-1561. doi: 10.1007/s00423-021-02158-0. Epub 2021 Mar 29.
citation: Merki-Kunzli C, Kerstan-Huber M, Switalla D, Gisi D, Raptis DA, Greco N, Mungo G, Wirz M, Gloor S, Misirlic M, Breitenstein S, Tschuor C. Assessing the Value of Prehabilitation in Patients Undergoing Colorectal Surgery According to the Enhanced Recovery After Surgery (ERAS) Pathway for the Improvement of Postoperative Outcomes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Oct 27;6(10):e199. doi: 10.2196/resprot.7972.