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

Postoperative Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572155
• Other study ID #: S53497
• Status: Completed
• Phase: N/A
• First received: April 2, 2012
• Last updated: December 3, 2015
• Start date: March 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Ileus

Intervention

Procedure:
• Vagus stimulation 1
2 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA
• Vagus stimulation 2
2 times 2 minutes (beginning and end of surgery) stimulation at 20 Hz, 500 micro s, 2.5 mA

Locations

Country	Name	City	State
Belgium	University hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1)		From date of surgery until postoperative day 1.	No
Secondary	time to first flatus		From date of surgery until the date of discharge from the hospital.	No
Secondary	time to tolerance of oral food intake		From date of surgery until the date of discharge from the hospital	No
Secondary	time to tolerance of oral food intake AND first defecation		From date of surgery until the date of discharge from the hospital	No
Secondary	gastrointestinal symptoms (nausea, pain, bloating)		From date of surgery until the date of discharge from the hospital	No
Secondary	Time to first defecation		From date of surgery until the date of discharge from the hospital.	No