Condition category
Digestive System
Date applied
16/10/2017
Date assigned
18/10/2017
Last edited
18/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Specialty: Surgery, Primary sub-specialty: Colorectal Surgery; UKCRC code/ Disease: Oral and Gastrointestinal/ Other diseases of the digestive system

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 measures

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

31/12/2018

Reason abandoned

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

01/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St. James’s University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

University of Leeds

Sponsor details

Leeds
Leeds
LS2 9JT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

01/12/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes