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

NCT01572155 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-12-04

No results posted yet for this study

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)

Conditions

  • Postoperative Ileus

Interventions

PROCEDURE

Vagus stimulation 1

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

PROCEDURE

Vagus stimulation 2

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

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • KU Leuven

    lead OTHER

Principal Investigators

  • Guy Boeckxstaens, M.D. · Catholic University Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01572155 on ClinicalTrials.gov