Clinical trial NCT02524626: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve
Official title: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve: A Potential New Therapeutical Intervention for Shortening Postoperative Ileus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Ileus
Keywords: Vagus nerve stimulation
Postoperative ileus
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2015-08-17
Enrollment: 130
Sex: ALL
Minimum age (years): 18
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 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


Eligibility criteria: 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

Primary outcomes:
measure: The gastrointestinal transit (geometric mean)
timeFrame: From postoperative day 3 until postoperative day 7
Secondary outcomes:
measure: Gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1
timeFrame: From the date of surgery until postoperative day 1
measure: Time to first flatus
timeFrame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
measure: Time to tolerance of oral food intake
timeFrame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
measure: Time to tolerance of oral food intake and first defecation
timeFrame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
measure: Time to first defecation
timeFrame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
measure: Gastrointestinal symptoms (nausea, pain, vomiting, bloating)
timeFrame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
measure: Time to discharge from the hospital
timeFrame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
measure: Levels of pro-inflammatory cytokines in intestinal tissue, serum, peritoneal lavage and supernatant of stimulated whole blood
timeFrame: From the date of surgery until the date of lab analysis (up to 6 months)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
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.