pre-TAPIOCA: Tibial Nerve Stimulation and Postoperative Ileus

Sponsor

University Hospital, Angers (Other)

Overall Status

Completed

CT.gov ID

NCT02815956

Collaborator

(none)

Enrollment

Location

Arms

8.1

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Ileus	Device: percutaneous tibial nerve stimulation Device: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 4, 2016

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

Jun 9, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: percutaneous tibial nerve stimulation
Placebo Comparator: 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.	Device: Placebo

Arm

Intervention/Treatment

Experimental: 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.

Device: percutaneous tibial nerve stimulation

Placebo Comparator: placebo (P)

Device: Placebo

Outcome Measures

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. [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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Center	Angers		France

Sponsors and Collaborators

University Hospital, Angers

Investigators

Principal Investigator: Aurélien Venara, MD, University Hospital Center of Angers

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT02815956

Other Study ID Numbers:

2016-A00438-43

First Posted:

Jun 28, 2016

Last Update Posted:

Nov 1, 2017

Last Verified:

Oct 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by University Hospital, Angers

percutaneous tibial nerve stimulation

randomized

controlled study

Additional relevant MeSH terms:

Ileus

Study Results

No Results Posted as of Nov 1, 2017