Colorectal Surgery Digestive System Postoperative ileus (POI)
Conditions
Interventions
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 w
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time taken to first bowel movement is measured according to daily clinical enquiry. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 & TNFa 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactStephen Chapman
Outcome results
None listed