CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Vagus stimulation 1 +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01572155
NCT01572155N/ACompleted

Pilot Study: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve: Potential New Therapeutic Intervention to Shorten Postoperative Ileus

KU Leuven·interventional·Posted Apr 6, 2012·Updated Dec 4, 2015

In Brief

A clinical study evaluating Vagus stimulation 1 and Vagus stimulation 2 for Postoperative Ileus. Completed, enrolled 24 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 6, 2012
Enrollment StartMar 1, 2012
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.2 years ago

Interventions

Vagus stimulation 1procedure

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

Vagus stimulation 2procedure

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