Tibial Nerve Stimulation and Postoperative Ileus
NCT02815956 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2017-11-01
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.
Conditions
- Postoperative Ileus
Interventions
- DEVICE
-
percutaneous tibial nerve stimulation
- DEVICE
-
Placebo
Sponsors & Collaborators
-
University Hospital, Angers
lead OTHER_GOV
Principal Investigators
-
Aurélien Venara, MD · University Hospital Center of Angers
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-04
- Primary Completion
- 2017-05-31
- Completion
- 2017-06-09
Countries
- France
Study Locations
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