CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 130 enrolled
Drug / intervention
Sham stimulation +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/NCT02524626
NCT02524626Phase 3Completed

Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve: A Potential New Therapeutical Intervention for Shortening Postoperative Ileus

KU Leuven·interventional·Posted Aug 17, 2015·Updated Feb 10, 2023

In Brief

A Phase 3 clinical trial evaluating Sham stimulation and Vagus stimulation for Postoperative Ileus. Completed, enrolled 130 participants across 1 site.

Detailed Summary

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: 1. to determine whether vagus nerve stimulation leads to an improvement in gastrointestinal transit using radiological testing 2. to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (daily questionnaire) 3. to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery

Study Details

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

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 17, 2015
Enrollment StartJul 1, 2017
Primary CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 10.9 years ago

Interventions

Sham stimulationprocedure

Sham stimulation

Vagus stimulationprocedure

Vagus stimulation