Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve

Postoperative Ileus Clinical Trial

Official title:

Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve: A Potential New Therapeutical Intervention for Shortening Postoperative Ileus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524626
• Other study ID #: S56309
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2023
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

Procedure:
• Sham stimulation
Sham stimulation
• Vagus stimulation
Vagus stimulation

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Universitaire Ziekenhuizen KU 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. doi: 10.1097/00000658-199811000-00004. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The gastrointestinal transit (geometric mean)		From postoperative day 3 until postoperative day 7
Secondary	Gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1		From the date of surgery until postoperative day 1
Secondary	Time to first flatus		From the date of surgery until the date of discharge from the hospital (on average 14 days)
Secondary	Time to tolerance of oral food intake		From the date of surgery until the date of discharge from the hospital (on average 14 days)
Secondary	Time to tolerance of oral food intake and first defecation		From the date of surgery until the date of discharge from the hospital (on average 14 days)
Secondary	Time to first defecation		From the date of surgery until the date of discharge from the hospital (on average 14 days)
Secondary	Gastrointestinal symptoms (nausea, pain, vomiting, bloating)		From the date of surgery until the date of discharge from the hospital (on average 14 days)
Secondary	Time to discharge from the hospital		From the date of surgery until the date of discharge from the hospital (on average 14 days)
Secondary	Levels of pro-inflammatory cytokines in intestinal tissue, serum, peritoneal lavage and supernatant of stimulated whole blood		From the date of surgery until the date of lab analysis (up to 6 months)