Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2016-10-04
2017-06-09
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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percutaneous tibial nerve stimulation (ST)
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.
percutaneous tibial nerve stimulation
placebo (P)
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.
Placebo
Interventions
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percutaneous tibial nerve stimulation
Placebo
Eligibility Criteria
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Inclusion Criteria
* elective colectomy or proctectomy
* agreement for the research
Exclusion Criteria
* irritable bowel disease documented
* history of surgery on oesophagus or stomach
* acetylcholine dysfunction
* enterostoma
* patient holder of pace-maker
18 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Aurélien Venara, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Center of Angers
Locations
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University Hospital Center
Angers, , France
Countries
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Other Identifiers
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2016-A00438-43
Identifier Type: -
Identifier Source: org_study_id