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

• Sponsor: KU Leuven (Other)
• Overall Status: Completed
• CT.gov ID: NCT01572155
• Collaborator: Universitaire Ziekenhuizen Leuven (Other)
• Enrollment: 24
• Location: 1
• Arms: 3
• Duration (Months): 45
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Postoperative Ileus	Procedure: Vagus stimulation 1; Procedure: Vagus stimulation 2	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1) [From date of surgery until postoperative day 1.]

2. time to first flatus [From date of surgery until the date of discharge from the hospital.]

3. time to tolerance of oral food intake [From date of surgery until the date of discharge from the hospital]

4. time to tolerance of oral food intake AND first defecation [From date of surgery until the date of discharge from the hospital]

5. gastrointestinal symptoms (nausea, pain, bloating) [From date of surgery until the date of discharge from the hospital]

6. Time to first defecation [From date of surgery until the date of discharge from the hospital.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University hospitals Leuven	Leuven	Vlaams-Brabant	Belgium	3000

Sponsors and Collaborators

• KU Leuven
• Universitaire Ziekenhuizen Leuven

Investigators

• Principal Investigator: Guy Boeckxstaens, M.D., Catholic University Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Guy Boeckxstaens, Principal Investigator, KU Leuven
• ClinicalTrials.gov Identifier: NCT01572155
• Other Study ID Numbers: S53497
• First Posted: Apr 6, 2012
• Last Update Posted: Dec 4, 2015
• Last Verified: Dec 1, 2015

• Additional relevant MeSH terms: Ileus

Study Results

No Results Posted as of Dec 4, 2015