Tibial Nerve Stimulation and Postoperative Ileus
- Conditions
- Postoperative Ileus
- Registration Number
- NCT02815956
- Lead Sponsor
- University Hospital, Angers
- Brief 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.
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- patients > 18 years
- elective colectomy or proctectomy
- agreement for the research
- chronic inflammatory bowel disease
- irritable bowel disease documented
- history of surgery on oesophagus or stomach
- acetylcholine dysfunction
- enterostoma
- patient holder of pace-maker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Center
🇫🇷Angers, France
University Hospital Center🇫🇷Angers, France