Tibial Nerve Stimulation and Postoperative Ileus

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02815956

Acronym

pre-TAPIOCA

Enrollment

Registered

2016-06-28

Start date

2016-10-04

Completion date

2017-06-09

Last updated

2017-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Ileus

Keywords

percutaneous tibial nerve stimulation, randomized, controlled study

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.

Interventions

DEVICEpercutaneous tibial nerve stimulation

DEVICEPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026