Postoperative Ileus
Conditions
Brief summary
Hypothesis: Electrical stimulation of the abdominal vagus nerve has an anti-inflammatory effect and represents a new therapeutic approach to shorten postoperative ileus. Aims: In the present pilot study, the investigators want to evaluate the anti-inflammatory effect of peroperative electrical stimulation of the vagus nerve. To this end, the following aims are formulated: 1. to optimize the technique of intra-operative electrical vagus nerve stimulation 2. to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery 3. to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (collect pilot data)
Interventions
PROCEDUREVagus stimulation 1
2 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA
PROCEDUREVagus stimulation 2
2 times 2 minutes (beginning and end of surgery) stimulation at 20 Hz, 500 micro s, 2.5 mA
Sponsors
Universitaire Ziekenhuizen KU Leuven
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with rectal carcinoma eligible for open rectal resection * Age between 18 and 70 years
Exclusion criteria
* Preoperative therapeutic abdominal radiation * Evident intra-abdominal inflammation (diagnosed by imaging and/or laboratory test results, including abscess or cholecystitis) * American Society of Anesthesiologists physical-health status classification (ASA-PS) \>3 * Poorly regulated diabetes (\>200 mg/dl (=11mmol/l))
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| levels of pro-inflammatory cytokines in serum, peritoneal lavage and supernatant of stimulated PBMCs (peripheral blood mononuclear cell) | From date of surgery until the date of lab analysis (in short time period after taking the blood sample) .Blood samples will be taken before surgery, 2, 24 and 48 hrs after surgery. |
Secondary
| Measure | Time frame |
|---|---|
| time to first flatus | From date of surgery until the date of discharge from the hospital. |
| time to tolerance of oral food intake | From date of surgery until the date of discharge from the hospital |
| gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1) | From date of surgery until postoperative day 1. |
| gastrointestinal symptoms (nausea, pain, bloating) | From date of surgery until the date of discharge from the hospital |
| Time to first defecation | From date of surgery until the date of discharge from the hospital. |
| time to tolerance of oral food intake AND first defecation | From date of surgery until the date of discharge from the hospital |
Countries
Belgium
Outcome results
None listed