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| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
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Hypothesis:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham stimulation + Placebo | Placebo Comparator |
|
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| Vagus stimulation + placebo | Active Comparator |
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| Prucalopride + sham stimulation | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagus stimulation | Procedure |
| ||
| Sham stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first flatus | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guy Boeckxstaens, M.D. | Catholic University Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospitals Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10486602 | Background | 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. | |
| 9833803 | Background | 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. |
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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| C406662 | prucalopride |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| Prucalopride | Drug |
|
| Placebo | Drug |
|
| 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 defecation | 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) |
| Time to discharge from the hospital | From the date of surgery until the date of discharge from the hospital (on average 14 days) |
| 30472681 | Derived | 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. |