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

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

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)

Study Overview

• Status: Completed
• Conditions: Postoperative Ileus
• Intervention / Treatment: Procedure: Vagus stimulation 1; Procedure: Vagus stimulation 2

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • University Hospitals Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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))

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
levels of pro-inflammatory cytokines in serum, peritoneal lavage and supernatant of stimulated PBMCs (peripheral blood mononuclear cell)	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

Outcome Measure	Time Frame
gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1)	From date of surgery until postoperative day 1.
time to first flatus	From date of surgery until the date of discharge from the hospital.
time to tolerance of oral food intake	From date of surgery until the date of discharge from the hospital
time to tolerance of oral food intake AND first defecation	From date of surgery until the date of discharge from the hospital
gastrointestinal symptoms (nausea, pain, bloating)	From date of surgery until the date of discharge from the hospital
Time to first defecation	From date of surgery until the date of discharge from the hospital.

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

General Publications

• Peters EG, De Jonge WJ, Smeets BJ, Luyer MD. The contribution of mast cells to postoperative ileus in experimental and clinical studies. Neurogastroenterol Motil. 2015 Jun;27(6):743-9. doi: 10.1111/nmo.12579.
• Kalff JC, Buchholz BM, Eskandari MK, Hierholzer C, Schraut WH, Simmons RL, Bauer AJ. Biphasic response to gut manipulation and temporal correlation of cellular infiltrates and muscle dysfunction in rat. Surgery. 1999 Sep;126(3):498-509.
• Kalff JC, Schraut WH, Simmons RL, Bauer AJ. Surgical manipulation of the gut elicits an intestinal muscularis inflammatory response resulting in postsurgical ileus. Ann Surg. 1998 Nov;228(5):652-63. doi: 10.1097/00000658-199811000-00004.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 2, 2012
• First Submitted That Met QC Criteria: April 4, 2012
• First Posted (Estimate): April 6, 2012

Study Record Updates

• Last Update Posted (Estimate): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 3, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus
• Other Study ID Numbers: S53497