Postoperative Ileuspre-TAPIOCANCT02815956
Tibial Nerve Stimulation and Postoperative Ileus
A study testing percutaneous tibial nerve stimulation in people with Postoperative Ileus, run by University Hospital, Angers at 1 site in France.
Trial summary
Postoperative ileus (POI) causes patient's discomfort and leads to an increase of cost of management after colorectal surgery because of an increase of the morbidity rate or of the rate of early rehospitalization after discharge. 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?
- percutaneous tibial nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2016to 9 Jun 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients > 18 years
- elective colectomy or proctectomy
- agreement for the research
Who cannot join
- chronic inflammatory bowel disease
- irritable bowel disease documented
- history of surgery on oesophagus or stomach
- acetylcholine dysfunction
- enterostoma
- patient holder of pace-maker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: InteresT And Mechanisms of Percutaneous Posterior tIbial Nerve Stimulation to Prevent pOstoperative Ileus in ColorectAl Surgery: A Preliminary Study
Postoperative ileus (POI) causes patient's discomfort and leads to an increase of cost of management after colorectal surgery because of an increase of the morbidity rate or of the rate of early rehospitalization after discharge.
Enhanced recovery programs allowed a reduction of its rate but 20 to 30% of patients will experiment POI.
Read more
A new approach during preoperative era, using mastication or preoperative physical activity, has been proposed to improve postoperative course. This leads to a vagal activation (action especially on upper GI).
Sacral stimulation using percutaneous tibial nerve stimulation (PTNS) has an effect on lower GI.
The aim of this study was to assess the efficacy and the feasibility of PTNS during perioperative course, to prevent POI with respect with placebo.
- Conditions
- Postoperative Ileus
- Being tested
- percutaneous tibial nerve stimulation, Placebo
- Keywords
- percutaneous tibial nerve stimulation, randomized, controlled study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous tibial nerve stimulationDevice
PlaceboDevice
| Study group | Role | What they receive |
|---|---|---|
| percutaneous tibial nerve stimulation (ST) | Experimental | Stimulation the day before surgery (x1), 30 minutes Stimulation the day of surgery, before surgery (at least 2 hours before surgery) and after surgery.
Stimulation every day (x3) after surgery until gastrointestinal functions recovery.
The protocol of stimulation is the same, that the one performed for fecal incontinence. Receives: Device: percutaneous tibial nerve stimulation |
| placebo (P) | Placebo comparator | Stimulation the day before surgery (x1), 30 minutes Stimulation the day of surgery, before surgery (at least 2 hours before surgery) and after surgery.
Stimulation every day (x3) after surgery until gastrointestinal functions recovery.
The device delivers ineffective impulses. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
delay before solid food tolerance and first stool recovery (expressed in days afters surgery). Day 0 (D0) is the day of surgery.
Measured: data collected from 6 hours after the end of surgery to the recovery. This recovery is expected to be between 1 and 6 days after surgery. Recovery will be assessed 3 times a day (7.00 am, 12.00 am, 6.00 pm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start4 Oct 2016
- Primary completionMay 2017
- Study completion9 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aurélien Venara, MD, Principal investigator, University Hospital Center of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815956
- Sponsor's protocol ID
- 2016-A00438-43
- Acronym
- pre-TAPIOCA
- Status last verified
- Oct 2017
- First submitted
- 16 Jun 2016
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InteresT And Mechanisms of Percutaneous Posterior tIbial Nerve Stimulation to Prevent pOstoperative Ileus in ColorectAl Surgery: A Preliminary Study
- ClinicalTrials.gov ID
- NCT02815956
- Acronym / sponsor ID
- pre-TAPIOCA / 2016-A00438-43
- Conditions
- Postoperative Ileus
- Keywords
- percutaneous tibial nerve stimulation, randomized, controlled study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 4 Oct 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- 9 Jun 2017 (actual)
- First posted
- 28 Jun 2016 (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.
Postoperative ileus (POI) causes patient's discomfort and leads to an increase of cost of management after colorectal surgery because of an increase of the morbidity rate or of the rate of early rehospitalization after discharge.
Enhanced recovery programs allowed a reduction of its rate but 20 to 30% of patients will experiment POI.
A new approach during preoperative era, using mastication or preoperative physical activity, has been proposed to improve postoperative course. This leads to a vagal activation (action especially on upper GI).
Sacral stimulation using percutaneous tibial nerve stimulation (PTNS) has an effect on lower GI.
The aim of this study was to assess the efficacy and the feasibility of PTNS during perioperative course, to prevent POI with respect with placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| percutaneous tibial nerve stimulation (ST) | Experimental | Device: percutaneous tibial nerve stimulationStimulation the day before surgery (x1), 30 minutes Stimulation the day of surgery, before surgery (at least 2 hours before surgery) and after surgery. Stimulation every day (x3) after surgery until gastrointestinal functions recovery. The protocol of stimulation is the same, that the one performed for fecal incontinence. |
| placebo (P) | Placebo comparator | Device: PlaceboStimulation the day before surgery (x1), 30 minutes Stimulation the day of surgery, before surgery (at least 2 hours before surgery) and after surgery. Stimulation every day (x3) after surgery until gastrointestinal functions recovery. The device delivers ineffective impulses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients > 18 years
- elective colectomy or proctectomy
- agreement for the research
Key exclusion criteria (6 listed)
- chronic inflammatory bowel disease
- irritable bowel disease documented
- history of surgery on oesophagus or stomach
- acetylcholine dysfunction
- enterostoma
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 |
|---|---|---|
| percutaneous tibial nerve stimulation | Device | percutaneous tibial nerve stimulation (ST) |
| Placebo | Device | placebo (P) |
Primary outcome
delay before solid food tolerance and first stool recovery (expressed in days afters surgery). Day 0 (D0) is the day of surgery.
Time frame: data collected from 6 hours after the end of surgery to the recovery. This recovery is expected to be between 1 and 6 days after surgery. Recovery will be assessed 3 times a day (7.00 am, 12.00 am, 6.00 pm)
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 1 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Aurélien Venara, MD principal investigator
University Hospital Center of Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous tibial nerve stimulation in people with Postoperative Ileus, run by University Hospital, Angers at 1 site in France.
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 3 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 1 Nov 2017. 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 France. 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.
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?
delay before solid food tolerance and first stool recovery (expressed in days afters surgery). Day 0 (D0) is the day of surgery. (time frame: data collected from 6 hours after the end of surgery to the recovery. This recovery is expected to be between 1 and 6 days after surgery. Recovery will be assessed 3 times a day (7.00 am, 12.00 am, 6.00 pm)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2017.