Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve

Study Overview
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Brief Summary
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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: to determine whether vagus nerve stimulation leads to an improvement in gastrointestinal transit using radiological testing to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (daily questionnaire) to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery

Official Title
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Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve: A Potential New Therapeutical Intervention for Shortening Postoperative Ileus

Conditions
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Postoperative Ileus

Intervention / Treatment
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* Procedure: Sham stimulation
* Procedure: Vagus stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with ovarium, pancreas or colorectal carcinoma eligible for resection Exclusion Criteria: preoperative therapeutic abdominal radiation shorter than 2 weeks prior to surgery 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 (= 11 mmol/l) surgery due to chronic pancreatitis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham stimulation<br>no stimulation of vagus nerve | Procedure: Sham stimulation<br>* Sham stimulation<br>|
| Active Comparator: Vagus stimulation<br>Stimulation of the vagus nerve at the beginning and the end of the surgery | Procedure: Vagus stimulation<br>* Vagus stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The gastrointestinal transit (geometric mean) |  | From postoperative day 3 until postoperative day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1 |  | From the date of surgery until postoperative day 1 | 
| Time to first flatus |  | From the date of surgery until the date of discharge from the hospital (on average 14 days) | 
| Time to tolerance of oral food intake |  | 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 |  | From the date of surgery until the date of discharge from the hospital (on average 14 days) | 
| Time to first defecation |  | From the date of surgery until the date of discharge from the hospital (on average 14 days) | 
| Gastrointestinal symptoms (nausea, pain, vomiting, bloating) |  | From the date of surgery until the date of discharge from the hospital (on average 14 days) | 
| Time to discharge from the hospital |  | 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 |  | From the date of surgery until the date of lab analysis (up to 6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vagus nerve stimulation, Postoperative ileus