Back to resultsTibial Nerve Stimulation and Postoperative Ileus (pre-TAPIOCA)
Primary Purpose
Postoperative Ileus
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
percutaneous tibial nerve stimulation
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Ileus focused on measuring percutaneous tibial nerve stimulation, randomized, controlled study
Eligibility Criteria
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
Sites / Locations
- University Hospital Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
percutaneous tibial nerve stimulation (ST)
placebo (P)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
delay before solid food tolerance and first stool recovery (expressed in days afters surgery). Day 0 (D0) is the day of surgery.
Secondary Outcome Measures
Full Information
NCT ID
NCT02815956
First Posted
June 16, 2016
Last Updated
October 30, 2017
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT02815956
Brief Title
Tibial Nerve Stimulation and Postoperative Ileus
Acronym
pre-TAPIOCA
Official Title
InteresT And Mechanisms of Percutaneous Posterior tIbial Nerve Stimulation to Prevent pOstoperative Ileus in ColorectAl Surgery: A Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 4, 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
June 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus
Keywords
percutaneous tibial nerve stimulation, randomized, controlled study
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
percutaneous tibial nerve stimulation (ST)
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo (P)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
percutaneous tibial nerve stimulation
Intervention Type
Device
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélien Venara, MD
Organizational Affiliation
University Hospital Center of Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Center
City
Angers
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Tibial Nerve Stimulation and Postoperative Ileus
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