Hypothesis: Electrical stimulation of the abdominal vagus nerve has anti-inflammatory effects which lead to a faster postoperative recovery after abdominal surgery. Aims: In the present study, the investigators want evaluate the anti-inflammatory effect of peroperative electrical stimulation of the vagus nerve. In addition, the investigators want to determine whether vagus nerve stimulation leads to a faster postoperative recovery. To this end, the following aims are formulated: 1. to determine whether vagus nerve stimulation leads to an improvement in gastrointestinal transit using radiological testing 2. to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (daily questionnaire) 3. to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
130
Sham stimulation
Vagus stimulation
University Hospitals Leuven
Leuven, Belgium
The gastrointestinal transit (geometric mean)
Time frame: From postoperative day 3 until postoperative day 7
Gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1
Time frame: From the date of surgery until postoperative day 1
Time to first flatus
Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to tolerance of oral food intake
Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to tolerance of oral food intake and first defecation
Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to first defecation
Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Gastrointestinal symptoms (nausea, pain, vomiting, bloating)
Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to discharge from the hospital
Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Levels of pro-inflammatory cytokines in intestinal tissue, serum, peritoneal lavage and supernatant of stimulated whole blood
Time frame: From the date of surgery until the date of lab analysis (up to 6 months)
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