Surgical Operation With Reversal of External StomapERACSNCT02746731
Prehabilitation - Enhanced Recovery After Colorectal Surgery
A study testing Cardiorespiratory and resistance training. and Reference in people with Surgical Operation With Reversal of External Stoma and Colorectal Surgery, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Operation With Reversal of External Stoma, Colorectal Surgery
- What is being tested?
- Cardiorespiratory and resistance training. and Reference
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2016to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401
About this study
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
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.
Read the 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.
- Being tested
- Cardiorespiratory and resistance training., Reference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
ReferenceOther
Also called Usual care.
No preoperative physical therapy training. Patients will be informed to remain physically active (as usual) until surgery.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | 'Cardiorespiratory and resistance training. Receives: Other: Cardiorespiratory and resistance training. |
| Reference | Active comparator | Usual care. Receives: Other: Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days
Secondary outcomes (4)
Clavien/Dindo
Assessment of post-surgical complications, ranging from Grade I (any deviation from normal postoperative Course) to Grade V (death of Patient).
Measured: 30 days
Five Times Sit to Stand Test
Time needed to raise from and sit-down on a chair for five times.
Measured: 30 days
2-Minute Walk Test
Distance covered within two minutes of brisk walking.
Measured: 30 days
Perceived pain
Numeric rating scale ranging from Zero (no pain) to ten (worst pain).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Surgical Operation With Reversal of External StomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich, Zurich University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Stefan Breitenstein, MD, PD, Study chair, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746731
- Sponsor's protocol ID
- pERACS
- Acronym
- pERACS
- Status last verified
- Mar 2019
- First submitted
- 18 Apr 2016
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 7891489Dindo 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.
PubMed 15273542Dronkers 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.
PubMed 23121372Slankamenac 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.
PubMed 23728278Gustafsson 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.
PubMed 23052794Gloor 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.
PubMed 35084526Taha 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.
PubMed 33782738Merki-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.
PubMed 29079551
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02746731
- Acronym / sponsor ID
- pERACS / pERACS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Collaborators
- University of Zurich, Zurich University of Applied Sciences
- Study start
- Jun 2016
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Other: Cardiorespiratory and resistance training.'Cardiorespiratory and resistance training. |
| Reference | Active comparator | Other: ReferenceUsual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Prehabilitation |
| ReferenceAlso: Usual care.No preoperative physical therapy training. Patients will be informed to remain physically active (as usual) until surgery. | Other | Reference |
Primary outcome
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).
4 secondary outcomes
Clavien/Dindo
Time frame: 30 days
Five Times Sit to Stand Test
Time frame: 30 days
2-Minute Walk Test
Time frame: 30 days
Perceived pain
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Background: PubMed 7891489Bardram 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.
- Background: PubMed 15273542Dindo 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.
- Background: PubMed 23121372Dronkers 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.
- Background: PubMed 23728278Slankamenac 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.
- Background: PubMed 23052794Gustafsson 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.
- Derived from this study: PubMed 35084526Gloor 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.
- Derived from this study: PubMed 33782738Taha 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.
- Derived from this study: PubMed 29079551Merki-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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Breitenstein, MD, PD study chair
Kantonsspital Winterthur KSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiorespiratory and resistance training. and Reference in people with Surgical Operation With Reversal of External Stoma and Colorectal Surgery, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Complication Index (CCI) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02746731, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.