Effect of a transcutaneous vagusnerve Stimulation of the ear on the muscle activity in the gastrointestinal tract as a potential therapeutic target to prevent postoperative Ileus (transVaGa)

Not Applicable

• Conditions: postoperative ileus; K56.0; Paralytic ileus

• Registration Number: DRKS00013340
• Lead Sponsor: Klinik und Poliklinik für Allgemein-, Viszeral-, Thorax- und GefäßchirurgieUniversitätsklinikum Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-10-24
• Study Start: 2017-11-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Patients who are at least18 years old and younger than 70 years old
-written informed consent
- Patients who undergo an elective, abdominal surgery with open laparotomy during colon-,small bowel-, gastric- oesophagus- or pancreas-resection.
-Patients, who are able to understand and follow the study protocol (comliance)
-negative pregnancy test (ß-HCG serum testing), if female patients don´t have a status after hysterectomy.

Exclusion Criteria

General exclusion criteria
-Age:<18 and >70 years
- patients who are not willing to participate
- patients, who are not able to understand the study and are not compliant
- patients who participate in another clinical trial at the same time or up to 30 days before the clinical Trial.
- Patient with an active implants (a.e. Cochlea-implant, vagusnerv-stimulator, Defibrillator)
- active drug abuse
- positive pregnancy or nursing period
Specific exclusion criteria:
- Gastritis
- stomach ulcer
- gastroparese
- Status after gastrectomy
- diabetes
- neuropthological diseases
- emergency surgery
- increased bleeding tendency
- intake of anticholinergic drugs
- patients with uncontrolled, severe diseases, a.e. instable heart condition, parkinson´s disease, hepatic or renal failure.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome: Activation of visceral fibers after electrical stimulation of the ear.<br>EMG of the stomach was performed for 5 minutes as a control. Next, EMG was carried out during tVNS with 10 mA, 25 Hz and 250 µs for 10 minutes.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome:<br>- Changes of heart rate<br>- Changes in gastrin concentration in the blood<br>- time of first bowel movement<br>- immune function analysis