Tibial Nerve Stimulation and Postoperative Ileus

NCT02815956 | Completed DMC

• 1 other identifier: 2016-A00438-43
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Ileus

Keywords

percutaneous tibial nerve stimulation; randomized; controlled study

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

percutaneous tibial nerve stimulation (ST)

EXPERIMENTAL

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 (P)

PLACEBO COMPARATOR

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

Interventions

percutaneous tibial nerve stimulation DEVICE

percutaneous tibial nerve stimulation (ST)

Placebo DEVICE

placebo (P)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients \> 18 years
• elective colectomy or proctectomy
• agreement for the research

You may not qualify if:

• chronic inflammatory bowel disease
• irritable bowel disease documented
• history of surgery on oesophagus or stomach
• acetylcholine dysfunction
• enterostoma
• patient holder of pace-maker

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University Hospital Center

Angers, France

Location

Study Officials

• Aurélien Venara, MD

  University Hospital Center of Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 28, 2016
• Study Start: October 4, 2016
• Primary Completion: May 1, 2017
• Study Completion: June 9, 2017
• Last Updated: November 1, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)