Transcutaneous vagal nerve stimulation & postoperative bowel functio

Phase 2

Completed

• Conditions: Colorectal Surgery; Digestive System; Postoperative ileus (POI)

• Registration Number: ISRCTN10693903
• Lead Sponsor: niversity of Leeds

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33539637/ (added 13/09/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-18
• Study Completion: 2019-12-01
• Last Update Posted: 27 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time taken to first bowel movement is measured according to daily clinical enquiry.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Time to first flatus is measured according to daily clinical enquiry<br> 2. Time to oral tolerance (solid food in the absence of vomiting) is measured according to daily clinical enquiry<br> 3. Serum cytokines IL1b, IL6 & TNFa are measured by blood draw on postoperative days 1 and 3<br> 4. Small bowel motility is measured using a quantitative score generated by Magnetic resonance enterography (MRE) studies<br>