Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve

Phase 3

Completed

• Conditions: Postoperative Ileus
• Interventions: Procedure: Sham stimulation; Procedure: Vagus stimulation

• Registration Number: NCT02524626
• Lead Sponsor: KU Leuven

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-17
• Study Start: 2017-07-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham stimulation	Sham stimulation	no stimulation of vagus nerve
Vagus stimulation	Vagus stimulation	Stimulation of the vagus nerve at the beginning and the end of the surgery

Primary Outcome Measures

Name	Time	Method
The gastrointestinal transit (geometric mean)	From postoperative day 3 until postoperative day 7

Secondary Outcome Measures

Name	Time	Method
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)
Time to first flatus	From the date of surgery until the date of discharge from the hospital (on average 14 days)
Gastrointestinal symptoms (nausea, pain, vomiting, bloating)	From the date of surgery until the date of discharge from the hospital (on average 14 days)
Gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1	From the date of surgery until postoperative day 1
Time to first defecation	From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to tolerance of oral food intake	From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to discharge from the hospital	From the date of surgery until the date of discharge from the hospital (on average 14 days)
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)

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium