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Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve

NCT02524626 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-02-10

No results posted yet for this study

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

Conditions

  • Postoperative Ileus

Interventions

PROCEDURE

Sham stimulation

Sham stimulation

PROCEDURE

Vagus stimulation

Vagus stimulation

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2019-12-31
Completion
2019-12-31

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 NCT02524626 on ClinicalTrials.gov