Prehabilitation - Enhanced Recovery After Colorectal Surgery

NCT02746731 | Completed

• 1 other identifier: pERACS
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Operation With Reversal of External Stoma; Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Clavien/Dindo

  30 days

• Five Times Sit to Stand Test

  30 days

• 2-Minute Walk Test

  30 days

• Perceived pain

  30 days

Other Outcomes (5)

• The self-reported International Physical Activity Questionnaire short-form (IPAQ-SF)

  30 days

• hand grip strength

  30 days

• Rating of Perceived Exertion

  30 days

Study Arms (2)

Prehabilitation

EXPERIMENTAL

'Cardiorespiratory and resistance training.

Other: Cardiorespiratory and resistance training.

Reference

ACTIVE COMPARATOR

Usual care.

Other: Reference

Interventions

Cardiorespiratory and resistance training. OTHER

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.

Prehabilitation

Reference OTHER

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

Also known as: Usual care.

Reference

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kantonsspital Winterthur KSW: lead
• University of Zurich: collaborator
• Zurich University of Applied Sciences: collaborator

Study Sites (1)

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

Location

Related Publications (8)

• 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.

  PMID: 7891489 BACKGROUND

• 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.

  PMID: 15273542 BACKGROUND

• 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.

  PMID: 23121372 BACKGROUND

• 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.

  PMID: 23728278 BACKGROUND

• 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.

  PMID: 23052794 BACKGROUND

• 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.

  PMID: 35084526 DERIVED

• 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.

  PMID: 33782738 DERIVED

• 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.

  PMID: 29079551 DERIVED

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stefan Breitenstein, MD, PD

  Kantonsspital Winterthur KSW

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 21, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 22, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)