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Clinical Trials/ISRCTN62033341
ISRCTN62033341
Completed
未知

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

niversity of Leeds0 sites97 target enrollmentOctober 11, 2019

Overview

Phase
未知
Intervention
Not specified
Conditions
Colorectal Surgery
Sponsor
niversity of Leeds
Enrollment
97
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Registry
who.int
Start Date
October 11, 2019
End Date
April 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Leeds

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Not specified

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