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

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ClinicalTrials.gov Identifier: NCT01572155
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : December 4, 2015
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Guy Boeckxstaens, Katholieke Universiteit Leuven

Brief 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)

Condition or disease Intervention/treatment Phase
Postoperative Ileus Procedure: Vagus stimulation 1 Procedure: Vagus stimulation 2 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve: Potential New Therapeutic Intervention to Shorten Postoperative Ileus
Study Start Date : March 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
No Intervention: Sham stimulation
No stimulation of nervus vagus
Active Comparator: 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 1
2 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA

Active Comparator: Vagus stimulation 2
2 times 2 minutes (beginning and end of surgery) stimulation at 20 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




Primary Outcome Measures :
  1. levels of pro-inflammatory cytokines in serum, peritoneal lavage and supernatant of stimulated PBMCs (peripheral blood mononuclear cell) [ Time Frame: From date of surgery until the date of lab analysis (in short time period after taking the blood sample) .Blood samples will be taken before surgery, 2, 24 and 48 hrs after surgery. ]

Secondary Outcome Measures :
  1. gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1) [ Time Frame: From date of surgery until postoperative day 1. ]
  2. time to first flatus [ Time Frame: From date of surgery until the date of discharge from the hospital. ]
  3. time to tolerance of oral food intake [ Time Frame: From date of surgery until the date of discharge from the hospital ]
  4. time to tolerance of oral food intake AND first defecation [ Time Frame: From date of surgery until the date of discharge from the hospital ]
  5. gastrointestinal symptoms (nausea, pain, bloating) [ Time Frame: From date of surgery until the date of discharge from the hospital ]
  6. Time to first defecation [ Time Frame: From date of surgery until the date of discharge from the hospital. ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with rectal carcinoma eligible for open rectal resection
  • Age between 18 and 70 years

Exclusion Criteria:

  • Preoperative therapeutic abdominal radiation
  • 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 (=11mmol/l))

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572155


Locations
Belgium
University hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Guy Boeckxstaens, M.D. Catholic University Leuven

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guy Boeckxstaens, Principal Investigator, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01572155     History of Changes
Other Study ID Numbers: S53497
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Inflammatory Agents