Postoperative Ileus
Conditions
Keywords
Prucalopride, Vagus Nerve Stimulation, Postoperative Ileus
Brief summary
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: 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
Interventions
Sponsors
KU Leuven
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients undergoing partial or full resection of the pancreas due to a benign or malignant tumor
Exclusion criteria
* adjuvant radiotherapy * 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))
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | 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) |
| 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) |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORGuy Boeckxstaens, M.D.
Catholic University Leuven
Outcome results
None listed