Tibial Nerve Stimulation and Postoperative Ileus

Postoperative Ileus Clinical Trial

— pre-TAPIOCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02815956
• Other study ID #: 2016-A00438-43
• Status: Completed
• Phase: N/A
• First received: June 16, 2016
• Last updated: October 30, 2017
• Start date: October 4, 2016
• Est. completion date: June 9, 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 9, 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

Device:
• percutaneous tibial nerve stimulation

• Placebo

Locations

Country	Name	City	State
France	University Hospital Center	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)