Clinical trial NCT01572155: Pilot Study: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve
Official title: Pilot Study: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve: Potential New Therapeutic Intervention to Shorten Postoperative Ileus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Ileus
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2012-04-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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))

Primary outcomes:
measure: levels of pro-inflammatory cytokines in serum, peritoneal lavage and supernatant of stimulated PBMCs (peripheral blood mononuclear cell)
timeFrame: 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:
measure: gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1)
timeFrame: From date of surgery until postoperative day 1.
measure: time to first flatus
timeFrame: From date of surgery until the date of discharge from the hospital.
measure: time to tolerance of oral food intake
timeFrame: From date of surgery until the date of discharge from the hospital
measure: time to tolerance of oral food intake AND first defecation
timeFrame: From date of surgery until the date of discharge from the hospital
measure: gastrointestinal symptoms (nausea, pain, bloating)
timeFrame: From date of surgery until the date of discharge from the hospital
measure: Time to first defecation
timeFrame: From date of surgery until the date of discharge from the hospital.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Catholic University Leuven
name: Guy Boeckxstaens, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1097/00000658-199811000-00004.
citation: 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.