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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
2 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA
2 times 2 minutes (beginning and end of surgery) stimulation at 20 Hz, 500 micro s, 2.5 mA
University hospitals Leuven
Leuven, Vlaams-Brabant, Belgium
levels of pro-inflammatory cytokines in serum, peritoneal lavage and supernatant of stimulated PBMCs (peripheral blood mononuclear cell)
Time frame: 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.
gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1)
Time frame: From date of surgery until postoperative day 1.
time to first flatus
Time frame: From date of surgery until the date of discharge from the hospital.
time to tolerance of oral food intake
Time frame: From date of surgery until the date of discharge from the hospital
time to tolerance of oral food intake AND first defecation
Time frame: From date of surgery until the date of discharge from the hospital
gastrointestinal symptoms (nausea, pain, bloating)
Time frame: From date of surgery until the date of discharge from the hospital
Time to first defecation
Time frame: From date of surgery until the date of discharge from the hospital.
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