Postoperative IleusNCT01572155
Pilot Study: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve
A study testing Vagus stimulation 1 and Vagus stimulation 2 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 an anti-inflammatory effect and represents a new therapeutic approach to shorten postoperative ileus. Aims: In the present pilot study, the investigators want to evaluate the anti-inflammatory effect of peroperative electrical stimulation of the vagus… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Vagus stimulation 1 and Vagus stimulation 2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2012to Dec 2015
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with rectal carcinoma eligible for open rectal resection
- Age between 18 and 70 years
Who cannot join
- Preoperative therapeutic abdominal radiation
- 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 (=11mmol/l))
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve: Potential New Therapeutic Intervention to Shorten Postoperative Ileus
Hypothesis:
Electrical stimulation of the abdominal vagus nerve has an anti-inflammatory effect and represents a new therapeutic approach to shorten postoperative ileus.
Aims:
In the present pilot study, the investigators want to evaluate the anti-inflammatory effect of peroperative electrical stimulation of the vagus nerve. To this end, the following aims are formulated:
- to optimize the technique of intra-operative electrical vagus nerve stimulation
- to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery
- to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (collect pilot data)
- Conditions
- Postoperative Ileus
- Being tested
- Vagus stimulation 1, Vagus stimulation 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus stimulation 1Procedure or surgery
2 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA
Vagus stimulation 2Procedure or surgery
2 times 2 minutes (beginning and end of surgery) stimulation at 20 Hz, 500 micro s, 2.5 mA
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation | No intervention | No stimulation of nervus vagus |
| Vagus stimulation 1 | Active comparator | 2 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA Receives: Procedure: Vagus stimulation 1 |
| Vagus stimulation 2 | Active comparator | 2 times 2 minutes (beginning and end of surgery) stimulation at 20 Hz, 500 micro s, 2.5 mA Receives: Procedure: Vagus stimulation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of pro-inflammatory cytokines in serum, peritoneal lavage and supernatant of stimulated PBMCs (peripheral blood mononuclear cell)
Measured: From date of surgery until the date of lab analysis (in short time period after taking the blood sample) .Blood samples will be taken before surgery, 2, 24 and 48 hrs after surgery.
Secondary outcomes (6)
gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1)
Measured: From date of surgery until postoperative day 1.
time to first flatus
Measured: From date of surgery until the date of discharge from the hospital.
time to tolerance of oral food intake
Measured: From date of surgery until the date of discharge from the hospital
time to tolerance of oral food intake AND first defecation
Measured: From date of surgery until the date of discharge from the hospital
gastrointestinal symptoms (nausea, pain, bloating)
Measured: From date of surgery until the date of discharge from the hospital
Time to first defecation
Measured: From date of surgery until the date of discharge from the hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2015
- Study completionDec 2015
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 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
- NCT01572155
- Sponsor's protocol ID
- S53497
- Status last verified
- Dec 2015
- First submitted
- 2 Apr 2012
- Last updated
- 4 Dec 2015
- 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 9833803Peters EG, De Jonge WJ, Smeets BJ, Luyer MD. The contribution of mast cells to postoperative ileus in experimental and clinical studies. Neurogastroenterol Motil. 2015 Jun;27(6):743-9. doi: 10.1111/nmo.12579.
PubMed 26011782
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve: Potential New Therapeutic Intervention to Shorten Postoperative Ileus
- ClinicalTrials.gov ID
- NCT01572155
- Acronym / sponsor ID
- S53497
- Conditions
- Postoperative Ileus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- Mar 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Apr 2012 (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 an anti-inflammatory effect and represents a new therapeutic approach to shorten postoperative ileus.
Aims:
In the present pilot study, the investigators want to evaluate the anti-inflammatory effect of peroperative electrical stimulation of the vagus nerve. To this end, the following aims are formulated:
- to optimize the technique of intra-operative electrical vagus nerve stimulation
- to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery
- to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (collect pilot data)
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 | No intervention | –No stimulation of nervus vagus |
| Vagus stimulation 1 | Active comparator | Procedure: Vagus stimulation 12 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA |
| Vagus stimulation 2 | Active comparator | Procedure: Vagus stimulation 22 times 2 minutes (beginning and end of surgery) stimulation at 20 Hz, 500 micro s, 2.5 mA |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with rectal carcinoma eligible for open rectal resection
- Age between 18 and 70 years
Key exclusion criteria (4 listed)
- Preoperative therapeutic abdominal radiation
- 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 (=11mmol/l))
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 12 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA | Procedure or surgery | Vagus stimulation 1 |
| Vagus stimulation 22 times 2 minutes (beginning and end of surgery) stimulation at 20 Hz, 500 micro s, 2.5 mA | Procedure or surgery | Vagus stimulation 2 |
Primary outcome
levels of pro-inflammatory cytokines in serum, peritoneal lavage and supernatant of stimulated PBMCs (peripheral blood mononuclear cell)
Time frame: From date of surgery until the date of lab analysis (in short time period after taking the blood sample) .Blood samples will be taken before surgery, 2, 24 and 48 hrs after surgery.
6 secondary outcomes
gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1)
Time frame: From date of surgery until postoperative day 1.
time to first flatus
Time frame: From date of surgery until the date of discharge from the hospital.
time to tolerance of oral food intake
Time frame: From date of surgery until the date of discharge from the hospital
time to tolerance of oral food intake AND first defecation
Time frame: From date of surgery until the date of discharge from the hospital
gastrointestinal symptoms (nausea, pain, bloating)
Time frame: From date of surgery until the date of discharge from the hospital
Time to first defecation
Time frame: From date of surgery until the date of discharge from the hospital.
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 4 Dec 2015.
- 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 26011782Peters EG, De Jonge WJ, Smeets BJ, Luyer MD. The contribution of mast cells to postoperative ileus in experimental and clinical studies. Neurogastroenterol Motil. 2015 Jun;27(6):743-9. doi: 10.1111/nmo.12579.
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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 study testing Vagus stimulation 1 and Vagus stimulation 2 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 2 inclusion and 4 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 4 Dec 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 serum, peritoneal lavage and supernatant of stimulated PBMCs (peripheral blood mononuclear cell) (time frame: From date of surgery until the date of lab analysis (in short time period after taking the blood sample) .Blood samples will be taken before surgery, 2, 24 and 48 hrs after surgery.). 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 NCT01572155, 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 4 Dec 2015.