Tibial Nerve Stimulation and Postoperative Ileus

Study Overview
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Brief Summary
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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.

Official Title
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InteresT And Mechanisms of Percutaneous Posterior tIbial Nerve Stimulation to Prevent pOstoperative Ileus in ColorectAl Surgery: A Preliminary Study

Conditions
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Postoperative Ileus

Intervention / Treatment
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* Device: percutaneous tibial nerve stimulation
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients > 18 years elective colectomy or proctectomy agreement for the research Exclusion Criteria: chronic inflammatory bowel disease irritable bowel disease documented history of surgery on oesophagus or stomach acetylcholine dysfunction enterostoma patient holder of pace-maker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: percutaneous tibial nerve stimulation (ST)<br>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. | Device: percutaneous tibial nerve stimulation<br> <br> |
| Placebo Comparator: placebo (P)<br>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. | Device: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delay before solid food tolerance and first stool recovery (expressed in days afters surgery). Day 0 (D0) is the day of surgery. |  | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous tibial nerve stimulation, randomized, controlled study