Transcutaneous vagal nerve stimulation & postoperative bowel function
| ISRCTN | ISRCTN10693903 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10693903 |
| Secondary identifying numbers | 35914 |
- Submission date
- 16/10/2017
- Registration date
- 18/10/2017
- Last edited
- 13/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Public
-
Leeds
-
United Kingdom
 ORCID ID |
0000-0003-2413-5690 |
|---|
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Prevention, Device |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | An investigation of transcutaneous vagal nerve stimulation on return of bowel function and inflammatory markers after colorectal surgery |
| Study objectives | 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(s) | North East: Tyne & Wear South Research Ethics Committee, 24/04/2017, ref: 17/NE/0091 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2017 |
| Completion date | 01/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 40; UK Sample Size: 40 |
| Total final enrolment | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2017 |
| Date of final enrolment | 31/08/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leeds
LS9 7TF
United Kingdom
Sponsor information
Hospital/treatment centre
Leeds
Leeds
LS2 9JT
England
United Kingdom
"ROR" |
https://ror.org/024mrxd33 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/03/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The datasets generated during and/or analysed during the current study are/will be available upon request. Proposals for further analyses should be submitted to the principal investigator (Stephen Chapman; stephen.chapman@doctors.org.uk) which will be reviewed by a statistician. If considered to be feasible, the proposer will be invited to work with the study team to undertake the analysis and reporting of results. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/05/2021 | 13/09/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/09/2021: Publication reference added.
01/12/2020: The intention to publish date was changed from 01/06/2020 to 31/03/2021. IPD sharing statement added.
23/09/2019: Total final enrolment number added.
23/07/2019: The recruitment end date has been changed from 01/06/2019 to 31/08/2019.
03/04/2019: The condition has been changed from "Specialty: Surgery, Primary sub-specialty: Colorectal Surgery; UKCRC code/ Disease: Oral and Gastrointestinal/ Other diseases of the digestive system" to "Colorectal Surgery" following a request from the NIHR.
11/02/2019 The following changes were made:
1. The recruitment end date was changed from: 31/01/2019 to 01/06/2019.
2. The overall end date was changed from: 01/06/2019 to 01/12/2019.
17/07/2018: The following changes have been made to the trial record:
1. The trial end date has been changed from 31/12/2018 to 01/06/2019
2. The recruitment end date has been changed from 01/03/2018 to 31/01/2019
3. The intention to publish date has been changed from 01/12/2019 to 01/06/2020
