Postoperative IleusPhase 4NCT02425774
Anti-inflammatory Effect of Pre-operative Stimulation of the Cholinergic Anti-Inflammatory Pathway
A Phase 4 study testing Vagus stimulation and Prucalopride in people with Postoperative Ileus, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Vagus stimulation and Prucalopride
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2014to 27 Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing partial or full resection of the pancreas due to a benign or malignant tumor
Who cannot join
- 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))
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-inflammatory Effect of Pre-operative Stimulation of the Cholinergic Anti-Inflammatory Pathway: A Potential New Therapeutical Intervention for Postoperative Ileus
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:
- to show that prucalopride has a similar inflammatory effect as abdominal vagus nerve stimulation (VNS)
- to evaluate whether prucalopride leads to accelerated post-operative recovery
- Conditions
- Postoperative Ileus
- Being tested
- Vagus stimulation, Sham stimulation, Prucalopride, Placebo
- Keywords
- Prucalopride, Vagus Nerve Stimulation, Postoperative Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus stimulationProcedure or surgery
Sham stimulationProcedure or surgery
PrucaloprideDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation + Placebo | Placebo comparator | * no stimulation
* 1 placebo tablet at two different timepoints before surgery Receives: Procedure: Sham stimulation; Drug: Placebo |
| Vagus stimulation + placebo | Active comparator | * Stimulation at the beginning and the end of the surgery
* 1 placebo tablet at two different timepoints before surgery Receives: Procedure: Vagus stimulation; Drug: Placebo |
| Prucalopride + sham stimulation | Active comparator | * 1 prucalopride tablet at two different timepoints before surgery
* no stimulation Receives: Procedure: Sham stimulation; Drug: Prucalopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of pro-inflammatory cytokines in intestinal tissue, serum, peritoneal lavage and supernatant of stimulated whole blood
Measured: From the date of surgery until the date of lab analysis (up to 6 months)
Secondary outcomes (6)
Time to first flatus
Measured: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to tolerance of oral food intake
Measured: 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
Measured: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to first defecation
Measured: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Gastrointestinal symptoms (nausea, pain, vomiting, bloating)
Measured: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to discharge from the hospital
Measured: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startJul 2014
- Primary completion27 Feb 2016
- Study completion27 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Guy Boeckxstaens, KU Leuven
- Investigators
- Guy Boeckxstaens, M.D., Principal investigator, Catholic University Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425774
- Sponsor's protocol ID
- S56328
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2015
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10486602Kalff 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.
PubMed 9833803Stakenborg 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.
PubMed 30472681
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory Effect of Pre-operative Stimulation of the Cholinergic Anti-Inflammatory Pathway: A Potential New Therapeutical Intervention for Postoperative Ileus
- ClinicalTrials.gov ID
- NCT02425774
- Acronym / sponsor ID
- S56328
- Conditions
- Postoperative Ileus
- Keywords
- Prucalopride, Vagus Nerve Stimulation, Postoperative Ileus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- Jul 2014
- Primary completion
- 27 Feb 2016 (actual)
- Study completion
- 27 Feb 2016 (actual)
- First posted
- 24 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to show that prucalopride has a similar inflammatory effect as abdominal vagus nerve stimulation (VNS)
- to evaluate whether prucalopride leads to accelerated post-operative recovery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham stimulation + Placebo | Placebo comparator | Procedure: Sham stimulation, Drug: Placebo* no stimulation * 1 placebo tablet at two different timepoints before surgery |
| Vagus stimulation + placebo | Active comparator | Procedure: Vagus stimulation, Drug: Placebo* Stimulation at the beginning and the end of the surgery * 1 placebo tablet at two different timepoints before surgery |
| Prucalopride + sham stimulation | Active comparator | Procedure: Sham stimulation, Drug: Prucalopride* 1 prucalopride tablet at two different timepoints before surgery * no stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing partial or full resection of the pancreas due to a benign or malignant tumor
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus stimulation | Procedure or surgery | Vagus stimulation + placebo |
| Sham stimulation | Procedure or surgery | Prucalopride + sham stimulation, Sham stimulation + Placebo |
| Prucalopride | Drug | Prucalopride + sham stimulation |
| Placebo | Drug | Sham stimulation + Placebo, Vagus stimulation + placebo |
Primary outcome
Levels of pro-inflammatory cytokines in intestinal tissue, serum, peritoneal lavage and supernatant of stimulated whole blood
Time frame: From the date of surgery until the date of lab analysis (up to 6 months)
6 secondary outcomes
Time to first flatus
Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to tolerance of oral food intake
Time frame: 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
Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to first defecation
Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Gastrointestinal symptoms (nausea, pain, vomiting, bloating)
Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Time to discharge from the hospital
Time frame: From the date of surgery until the date of discharge from the hospital (on average 14 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Background: PubMed 10486602Kalff 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.
- Background: PubMed 9833803Kalff 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.
- Derived from this study: PubMed 30472681Stakenborg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Boeckxstaens, M.D. principal investigator
Catholic University Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vagus stimulation and Prucalopride in people with Postoperative Ileus, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of pro-inflammatory cytokines in intestinal tissue, serum, peritoneal lavage and supernatant of stimulated whole blood (time frame: From the date of surgery until the date of lab analysis (up to 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02425774, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.