Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve

Catholic University (KU) of Leuven

Status and phase

Completed

Phase 3

Conditions

Postoperative Ileus

Treatments

Procedure: Vagus stimulation

Procedure: Sham stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02524626

S56309

Details and patient eligibility

About

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

Enrollment

130 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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