Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve

February 7, 2023 updated by: Guy Boeckxstaens, KU Leuven

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospitals Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with ovarium, pancreas or colorectal carcinoma eligible for resection

Exclusion Criteria:

  • preoperative therapeutic abdominal radiation shorter than 2 weeks prior to surgery
  • 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 (= 11 mmol/l)
  • surgery due to chronic pancreatitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Sham stimulation
no stimulation of vagus nerve
Procedure: Sham stimulation
Sham stimulation
ACTIVE_COMPARATOR: Vagus stimulation
Stimulation of the vagus nerve at the beginning and the end of the surgery
Procedure: Vagus stimulation
Vagus stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The gastrointestinal transit (geometric mean)
Time Frame: From postoperative day 3 until postoperative day 7
From postoperative day 3 until postoperative day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1
Time Frame: From the date of surgery until postoperative day 1
From the date of surgery until postoperative day 1
Time to first flatus
Time Frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to tolerance of oral food intake
Time Frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to tolerance of oral food intake and first defecation
Time Frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to first defecation
Time Frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Gastrointestinal symptoms (nausea, pain, vomiting, bloating)
Time Frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to discharge from the hospital
Time Frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Levels of pro-inflammatory cytokines in intestinal tissue, serum, peritoneal lavage and supernatant of stimulated whole blood
Time Frame: From the date of surgery until the date of lab analysis (up to 6 months)
From the date of surgery until the date of lab analysis (up to 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Collaborators

Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

May 7, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (ESTIMATE)

August 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S56309

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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