Postoperative IleusPhase 3NCT02524626
Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve
A Phase 3 study testing Vagus stimulation in people with Postoperative Ileus, run by KU Leuven at 1 site in Belgium.
Trial summary
Hypothesis: 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. 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2017to 31 Dec 2019
- Phase
- Phase 3
- 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 with ovarium, pancreas or colorectal carcinoma eligible for resection
Who cannot join
- preoperative therapeutic abdominal radiation shorter than 2 weeks prior to surgery
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve: A Potential New Therapeutical Intervention for Shortening Postoperative Ileus
Hypothesis:
Electrical stimulation of the abdominal vagus nerve has anti-inflammatory effects which lead to a faster postoperative recovery after abdominal surgery.
Read more
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:
- to determine whether vagus nerve stimulation leads to an improvement in gastrointestinal transit using radiological testing
- to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (daily questionnaire)
- to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery
- Conditions
- Postoperative Ileus
- Being tested
- Sham stimulation, Vagus stimulation
- Keywords
- Vagus nerve stimulation, Postoperative ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham stimulationProcedure or surgery
Sham stimulation
Vagus stimulationProcedure or surgery
Vagus stimulation
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation | Sham comparator | no stimulation of vagus nerve Receives: Procedure: Sham stimulation |
| Vagus stimulation | Active comparator | Stimulation of the vagus nerve at the beginning and the end of the surgery Receives: Procedure: Vagus stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The gastrointestinal transit (geometric mean)
Measured: From postoperative day 3 until postoperative day 7
Secondary outcomes (8)
Gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1
Measured: From the date of surgery until postoperative day 1
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)
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study start1 Jul 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 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
- NCT02524626
- Sponsor's protocol ID
- S56309
- Status last verified
- Feb 2023
- First submitted
- 7 May 2015
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 9833803
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve: A Potential New Therapeutical Intervention for Shortening Postoperative Ileus
- ClinicalTrials.gov ID
- NCT02524626
- Acronym / sponsor ID
- S56309
- Conditions
- Postoperative Ileus
- Keywords
- Vagus nerve stimulation, Postoperative ileus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 Aug 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:
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:
- to determine whether vagus nerve stimulation leads to an improvement in gastrointestinal transit using radiological testing
- to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (daily questionnaire)
- to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham stimulation | Sham comparator | Procedure: Sham stimulationno stimulation of vagus nerve |
| Vagus stimulation | Active comparator | Procedure: Vagus stimulationStimulation of the vagus nerve at the beginning and the end of the surgery |
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 with ovarium, pancreas or colorectal carcinoma eligible for resection
Key exclusion criteria (5 listed)
- preoperative therapeutic abdominal radiation shorter than 2 weeks prior to surgery
- 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
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 |
|---|---|---|
| Sham stimulationSham stimulation | Procedure or surgery | Sham stimulation |
| Vagus stimulationVagus stimulation | Procedure or surgery | Vagus stimulation |
Primary outcome
The gastrointestinal transit (geometric mean)
Time frame: From postoperative day 3 until postoperative day 7
8 secondary outcomes
Gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1
Time frame: From the date of surgery until postoperative day 1
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)
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)
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 10 Feb 2023.
- 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.
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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 3 study testing Vagus stimulation 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 5 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 10 Feb 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The gastrointestinal transit (geometric mean) (time frame: From postoperative day 3 until postoperative day 7). 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 NCT02524626, which also lists 2 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 10 Feb 2023.