Vagus nerve stimulation to improve bowel function after surgery

Not Applicable

Completed

• Conditions: Surgery; Colorectal Surgery

• Registration Number: ISRCTN62033341
• Lead Sponsor: niversity of Leeds

Brief Summary

2021 Protocol article in http://dx.doi.org/10.1136/bmjopen-2020-046313 (added 18/08/2021)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-11
• Study Completion: 2022-04-30
• Last Update Posted: 4 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

1. Aged > = 18 years
2. Able to provide written informed consent
3. Planned to undergo elective, minimally-invasive (laparoscopic or robotic), colorectal surgery

Exclusion Criteria

Main trial:
1. Confirmed STEMI or NSTEMI) in the last 12 months
2. Known congestive heart failure (NYHA> 2)
3. Confirmed 2nd/3rd degree heart block, permanent atrial fibrillation, or previous VT/VF
4. Seizures or recurrent episodes of syncope (> 1) in the last five years
5. Cerebrovascular disease (transient ischaemic attack or cerebral vascular accident)
6. Previous vagotomy at any anatomical location
7. Confirmed diagnosis of chronic gastrointestinal inflammatory condition (Crohn’s disease or UC)
8. Confirmed diagnosis of neuro-endocrine tumour (such as carcinoid)
9. Existing gastrointestinal stoma (including ileostomy or colostomy)
10. Implanted electrical stimulator device
11. Structural abnormality of the neck anatomy which may impact on use of the device
12. Belonging to a vulnerable population (homeless, developmentally disabled, prisoner)
13. Pregnant, nursing or thinking of becoming pregnant during the study period

Inflammatory sub-study (lead site only):
14. Regular use of NSAIDs in the preceding 7 days or medical condition requiring oral/injectable steroids
15. Neoadjuvant chemoradiotherapy within 12 months prior to surgery

Small bowel motility sub-study (lead site only):
16. Non-MR compatible implants, prostheses, neurosurgical clips, or foreign bodies, precluding safe MR imaging
17. Claustrophobia, or other barrier to laying supine for 30 minutes

Study & Design

• Study Type: Interventional
• Study Design: Not specified