Plain English Summary
Background and study aims
Surgery on the bowel often leads to postoperative ileus (POI) - a condition in which the bowel “goes to sleep”. In most patients, the bowel soon returns to normal, but in some patients POI is prolonged. This delays recovery and increases the risk of vomiting, constipation, breathing difficulties, and blood clots in the legs and lungs. A new device aims to minimise the occurrence of POI by stimulating the nerves to the bowel and reducing the time taken for return of normal bowel function. It is easy to use, has no known serious side-effects and the device can be used at home or in hospital. There is currently no effective treatment for POI. The aim of this study is to investigate whether the new treatment (stimulating the nerves to the bowel using a simple and safe device) will provide a much-needed solution to a long-standing problem and make surgery safer for patients.
Who can participate?
Adults aged 17 and older who have a confirmed colorectal cancer
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group receive a device to usetwice a day. Participants in the second group receive a “dummy” device which looks and feels the same but does not produce nerve stimulation. The treatment will be assessed in several ways, including: time taken for the bowel to recover, blood tests before and after surgery, an MRI scan to look at the bowel and patients’ acceptance of the device.
What are the possible benefits and risks of participating?
Participants may benefit from improvement in their symptoms. There are no expected risks with participating.
Where is the study run from?
St. James’s University Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2017 to December 2018
Who is funding the study?
Bowel Disease Research Foundation (BDRF) (UK)
Who is the main contact?
Mr Stephen Chapman
stephen.chapman@doctors.org.uk
Trial website
Contact information
Type
Public
Primary contact
Mr Stephen Chapman
ORCID ID
http://orcid.org/0000-0003-2413-5690
Contact details
-
Leeds
-
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
35914
Study information
Scientific title
An investigation of transcutaneous vagal nerve stimulation on return of bowel function and inflammatory markers after colorectal surgery
Acronym
Study hypothesis
The aim of the study is to investigate the effect of transcutaneous vagal nerve stimulation on the return of bowel function after colorectal surgery
Ethics approval
North East: Tyne & Wear South Research Ethics Committee, 24/04/2017, ref: 17/NE/0091
Study design
Randomised; Interventional; Design type: Treatment, Prevention, Device
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Colorectal Surgery
Intervention
Participants self-administer a hand held, non-invasive, vagal nerve stimulator device before and and after surgery.
Half of patients will have a functioning device and the other half will have a “dummy” device which looks and feels the same but does not produce nerve stimulation. This will allow the effect of the functioning device to be compared.
Bowel function is assessed daily, as well as postoperative assessments of systemic cytokine response and small bowel motility.
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measure
Time taken to first bowel movement is measured according to daily clinical enquiry.
Secondary outcome measures
1. Time to first flatus is measured according to daily clinical enquiry
2. Time to oral tolerance (solid food in the absence of vomiting) is measured according to daily clinical enquiry
3. Serum cytokines IL1b, IL6 & TNFα are measured by blood draw on postoperative days 1 and 3
4. Small bowel motility is measured using a quantitative score generated by Magnetic resonance enterography (MRE) studies
Overall trial start date
01/01/2017
Overall trial end date
01/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged greater than 17 years
2. Able to provide written informed consent
3. Able to use the device and comply with study procedures
4. Confirmed diagnosis of colorectal cancer via radiological or histological modalities
5. Undergoing elective laparoscopic colorectal resection
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 40; UK Sample Size: 40
Participant exclusion criteria
1. Acute infective or inflammatory condition
2. Pre-operative, therapeutic radiotherapy
3. Previous MI (STEMI/NSTEMI) or cerebrovascular disease (CVA/TIA) or known peripheral vascular disease
4. Known congestive heart failure (NYHA>2),
5. Known cardiac dysrhythmia (Previous VF, VT, AF, SVT, Heart block)
6. Known history of seizures or recurrent syncope in the last five years
7. Known chronic inflammatory condition of the gastrointestinal tract
8. Previous neck surgery, or other abnormality distorting the cervical anatomy
9. Previous vagotomy at any anatomical location
10. Any in-dwelling device, stimulator or non MR compatible metallic implant
11. Known or suspected intra-occular metallic bodies
12. Regular medication known to mediate systemic inflammation (e.g. NSAIDS)
13. Psychiatric, cognitive or behavioural problems which may affect study procedures
14. Belonging to a vulnerable population (homeless, prisoner)
15. Current pregnancy
Recruitment start date
01/11/2017
Recruitment end date
01/06/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St. James’s University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Funders
Funder type
Government
Funder name
Bowel Disease Research Foundation (BDRF)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication in a high-impact peer reviewed journal is planned within one year of trial closure (estimated 2018-2019).
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/06/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list