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)

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) - transVaGa

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013340

Enrollment

Registered

2017-11-28

Start date

2016-03-01

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

postoperative ileus K56.0

Interventions

Group 1: Patients were screened and included 21 days to at least 24h prior surgery. Included patient were anaesthetized via total intravenous anaethesia. After laparotomy, needle electrodes were place

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

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

Exclusion criteria: General exclusion criteria -Age: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.

Design outcomes

Primary

Measure	Time frame
Primary outcome: Activation of visceral fibers after electrical stimulation of the ear. 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

Measure	Time frame
Secondary outcome: - Changes of heart rate - Changes in gastrin concentration in the blood - time of first bowel movement - immune function analysis	—

Countries

Germany

Contacts

Public ContactGun-Soo Hong

Klinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie

Gun-Soo.Hong@ukbonn.de0049-228-28715109

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 4, 2026