Tibial Nerve Stimulation and Postoperative Ileus (pre-TAPIOCA)

October 30, 2017 updated by: University Hospital, Angers

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • University Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

June 9, 2017

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A00438-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Ileus

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe