Anti-inflammatory Effect of Pre-operative Stimulation of the Cholinergic Anti-Inflammatory Pathway
NCT ID: NCT02425774
Last Updated: 2023-02-08
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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RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2014-07-31
2025-12-31
Brief Summary
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Prucalopride can mimic electrical stimulation of the abdominal vagus nerve and has an anti-inflammatory effect.
Aims:
In the present pilot study, the investigators want to evaluate the anti-inflammatory effect of prucalopride. The following aims are formulated:
1. to show that prucalopride has a similar inflammatory effect as abdominal vagus nerve stimulation (VNS)
2. to evaluate whether prucalopride leads to accelerated post-operative recovery
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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 + Placebo
* no stimulation
* 1 placebo tablet at two different timepoints before surgery
Sham stimulation
Placebo
Vagus stimulation + placebo
* Stimulation at the beginning and the end of the surgery
* 1 placebo tablet at two different timepoints before surgery
Vagus stimulation
Placebo
Prucalopride + sham stimulation
* 1 prucalopride tablet at two different timepoints before surgery
* no stimulation
Sham stimulation
Prucalopride
Interventions
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Vagus stimulation
Sham stimulation
Prucalopride
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* evident intra-abdominal inflammation (diagnosed by imaging and/or laboratory results, including an abscess or cholecystitis)
* chronic pancreatitis
* pancreatic polypeptide producing endocrine tumor
* American Society of Anesthesiologists physical-health status classification (ASA-PS)\>3
* Poorly regulated diabetes (\>200 mg/dl (=11 mmol/l))
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, Vlaams-Brabant, Belgium
Countries
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Central Contacts
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Facility Contacts
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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.
Stakenborg N, Labeeuw E, Gomez-Pinilla PJ, De Schepper S, Aerts R, Goverse G, Farro G, Appeltans I, Meroni E, Stakenborg M, Viola MF, Gonzalez-Dominguez E, Bosmans G, Alpizar YA, Wolthuis A, D'Hoore A, Van Beek K, Verheijden S, Verhaegen M, Derua R, Waelkens E, Moretti M, Gotti C, Augustijns P, Talavera K, Vanden Berghe P, Matteoli G, Boeckxstaens GE. Preoperative administration of the 5-HT4 receptor agonist prucalopride reduces intestinal inflammation and shortens postoperative ileus via cholinergic enteric neurons. Gut. 2019 Aug;68(8):1406-1416. doi: 10.1136/gutjnl-2018-317263. Epub 2018 Nov 24.
Other Identifiers
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S56328
Identifier Type: -
Identifier Source: org_study_id
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