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NCT Number: NCT02524626

Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve

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

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Key information

Conditions

Postoperative Ileus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospitals Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Sham stimulation

Procedure

Sham stimulation

Vagus stimulation

Procedure

Vagus stimulation

Primary outcomes

  1. The gastrointestinal transit (geometric mean)

    Time frame: From postoperative day 3 until postoperative day 7

Secondary outcomes

  1. 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

  2. Time to first flatus

    Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)

  3. 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)

  4. 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)

  5. Time to first defecation

    Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)

  6. 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)

  7. 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)

  8. 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)

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 17, 2015
Registry last updated
Feb 10, 2023

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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