Tibial Nerve Stimulation and Postoperative Ileus (pre-TAPIOCA)

University Hospital, Angers

Status: Completed

Conditions: Postoperative Ileus

Treatments: Device: Placebo; Device: percutaneous tibial nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02815956

2016-A00438-43

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

percutaneous tibial nerve stimulation (ST)

Experimental group

Description:

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.

Treatment:

Device: percutaneous tibial nerve stimulation

placebo (P)

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo