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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02815956
Other study ID # 2016-A00438-43
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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