Colorectal Surgery Surgery Colorectal Surgery
Conditions
Interventions
A feasibility RCT will be performed at two research sites. This will involve patients randomly assigned to four groups:
1. Pre-operative active stimulation and post-operative sham stimulation
2. Pre-o
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As a feasibility study, the study does not have a primary defined outcome. Instead, it has a series of outcomes to confirm or refute the feasibility of a definite RCT. Measured at or up to 30 days after surgery: Outcomes to inform progression: 1. Proportion of eligible patients identified from screening logs 2. Number of eligible patients randomised (per month), including reasons for approach failure 3. Adequacy of participant blinding according to a blinding poll (Bang Blinding Index) 4. Compliance to the study treatment schedule according to participant-reported diaries 5. Proportion of randomised participants lost to follow up 6. Incidence of serious and unexpected serious complications Outcomes to explore clinical variability 1. Time to first passage of flatus 2. Time to first passage of stool 3. Time to first oral tolerance (tolerance of solid diet in the absence of vomiting for 12 hours) 4. Time to GI-2 (a composite of time to first oral tolerance and passage of first stool) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcomes for the optional sub-studies (lead site only) are described below. Inflammatory response sub-study: 1. Serum interleukin (IL) 1-beta, IL6, and tumour necrosis factor (TNF)-alpha at time points: 1.1. Morning of surgery – after pre-operative stimulation schedule/prior to surgery 1.2. 2-4 hours after start of surgery – measured from time of "knife-to-skin" 1.3. 24 hours after start of surgery – measured from time of "knife-to-skin" 1.4. 72 hours after start of surgery – measured from time of "knife-to-skin" 2. Peritoneal fluid IL-6, IL1-beta, and TNF alpha at time points: 2.1. Start of surgery – estimated 0-30 minutes after "knife-to-skin" 2.2. End of surgery – estimated 2-4 hours after "knife-to-skin" Small bowel motility sub-study: 1. Small bowel motility measured by assigning a validated GIQuant™ score to MR enterography scans | — |
Countries
England, United Kingdom
Outcome results
None listed