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

Not Applicable

Completed

• Conditions: Postoperative Ileus
• Interventions: Procedure: Vagus stimulation 1; Procedure: Vagus stimulation 2

• Registration Number: NCT01572155
• Lead Sponsor: KU Leuven

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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))

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vagus stimulation 1	Vagus stimulation 1	2 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA
Vagus stimulation 2	Vagus stimulation 2	2 times 2 minutes (beginning and end of surgery) stimulation at 20 Hz, 500 micro s, 2.5 mA

Primary Outcome Measures

Name	Time	Method
levels of pro-inflammatory cytokines in serum, peritoneal lavage and supernatant of stimulated PBMCs (peripheral blood mononuclear cell)	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.

Secondary Outcome Measures

Name	Time	Method
time to first flatus	From date of surgery until the date of discharge from the hospital.
gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1)	From date of surgery until postoperative day 1.
time to tolerance of oral food intake	From date of surgery until the date of discharge from the hospital
Time to first defecation	From date of surgery until the date of discharge from the hospital.
time to tolerance of oral food intake AND first defecation	From date of surgery until the date of discharge from the hospital
gastrointestinal symptoms (nausea, pain, bloating)	From date of surgery until the date of discharge from the hospital

Trial Locations

Locations (1)

University hospitals Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium