Tibial Nerve Stimulation and Postoperative Ileus

Not Applicable

Completed

• Conditions: Postoperative Ileus
• Interventions: Device: percutaneous tibial nerve stimulation; Device: Placebo

• Registration Number: NCT02815956
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-28
• Study Start: 2016-10-04
• Primary Completion: 2017-05
• Study Completion: 2017-06-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
percutaneous tibial nerve stimulation (ST)	percutaneous tibial nerve stimulation	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.
placebo (P)	Placebo	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.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University Hospital Center; 🇫🇷 Angers, France