Pilot Study: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve

Catholic University (KU) of Leuven

Status: Completed

Conditions: Postoperative Ileus

Treatments: Procedure: Vagus stimulation 1; Procedure: Vagus stimulation 2

Study type: Interventional

Funder types: Other

Identifiers

NCT01572155

S53497

Details and patient eligibility

About

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)

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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))

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 3 patient groups

Sham stimulation

No Intervention group

Description:

No stimulation of nervus vagus

Vagus stimulation 1

Active Comparator group

Description:

2 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA

Treatment:

Procedure: Vagus stimulation 1

Vagus stimulation 2

Active Comparator group

Description:

2 times 2 minutes (beginning and end of surgery) stimulation at 20 Hz, 500 micro s, 2.5 mA

Treatment:

Procedure: Vagus stimulation 2