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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Katholieke Universiteit Leuven
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Guy Boeckxstaens, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01572155
First received: April 2, 2012
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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 Intervention
Postoperative Ileus
Procedure: Vagus stimulation 1
Procedure: Vagus stimulation 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1) [ Time Frame: From date of surgery until postoperative day 1. ] [ Designated as safety issue: No ]
  • time to first flatus [ Time Frame: From date of surgery until the date of discharge from the hospital. ] [ Designated as safety issue: No ]
  • time to tolerance of oral food intake [ Time Frame: From date of surgery until the date of discharge from the hospital ] [ Designated as safety issue: No ]
  • time to tolerance of oral food intake AND first defecation [ Time Frame: From date of surgery until the date of discharge from the hospital ] [ Designated as safety issue: No ]
  • gastrointestinal symptoms (nausea, pain, bloating) [ Time Frame: From date of surgery until the date of discharge from the hospital ] [ Designated as safety issue: No ]
  • Time to first defecation [ Time Frame: From date of surgery until the date of discharge from the hospital. ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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))
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572155

Contacts
Contact: Winde Vanbrabant, MSc 0032-16-341943 winde.vanbrabant@med.kuleuven.be
Contact: Isabelle Terrasson 0032-16-340837 isabelle.terrasson@uzleuven.be

Locations
Belgium
University hospitals Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Winde Vanbrabant, MSc    0032-16-341943    winde.vanbrabant@med.kuleuven.be   
Contact: Isabelle Terrasson    0032-16-340837    isabelle.terrasson@uzleuven.be   
Principal Investigator: Guy Boeckxstaens, M.D.         
Sponsors and Collaborators
Katholieke Universiteit Leuven
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Guy Boeckxstaens, M.D. Catholic University Leuven
  More Information

Publications:
Responsible Party: Guy Boeckxstaens, Principal Investigator, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01572155     History of Changes
Other Study ID Numbers: S53497
Study First Received: April 2, 2012
Last Updated: July 14, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

ClinicalTrials.gov processed this record on July 23, 2014