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NCT Number: NCT01572155

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

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)

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Key information

Conditions

Postoperative Ileus

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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))

Treatment and study plan

Vagus stimulation 1

Procedure

2 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA

Vagus stimulation 2

Procedure

2 times 2 minutes (beginning and end of surgery) stimulation at 20 Hz, 500 micro s, 2.5 mA

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

Pilot Study: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve: Potential New Therapeutic Intervention to Shorten Postoperative Ileus

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 6, 2012
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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