Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve
NCT ID: NCT02524626
Last Updated: 2023-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
130 participants
INTERVENTIONAL
2017-07-01
2019-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sham stimulation
no stimulation of vagus nerve
Sham stimulation
Sham stimulation
Vagus stimulation
Stimulation of the vagus nerve at the beginning and the end of the surgery
Vagus stimulation
Vagus stimulation
Interventions
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Sham stimulation
Sham stimulation
Vagus stimulation
Vagus stimulation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
KU Leuven
OTHER
Responsible Party
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Guy Boeckxstaens
Principal Investigator
Principal Investigators
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Guy Boeckxstaens, M.D.
Role: PRINCIPAL_INVESTIGATOR
Catholic University Leuven
Locations
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University Hospitals Leuven
Leuven, , Belgium
Countries
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References
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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. doi: 10.1097/00000658-199811000-00004.
Other Identifiers
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S56309
Identifier Type: -
Identifier Source: org_study_id
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