Transcutaneous vagal nerve stimulation to reduce Ileus: A feasibility study (TRANSIT)

niversity of Leeds0 个研究点目标入组 97 人开始时间: 2019年10月11日最近更新: 2023年7月4日

适应症

试验速览

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

•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

发起方

niversity of Leeds