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Clinical Efficacy and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Postoperative Gastrointestinal Function Recovery in Patients Undergoing Robot-Assisted Laparoscopic Prostatectomy (RARP): A Randomized, Double-Blind, Placebo-Controlled Trial

Clinical Efficacy and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Postoperative Gastrointestinal Function Recovery in Patients Undergoing Robot-Assisted Laparoscopic Prostatectomy (RARP): A Randomized, Double-Blind, Placebo-Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121528
Enrollment
Unknown
Registered
2026-03-31
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Postoperative Gastrointestinal Dysfunction

Interventions

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age 50-80 years. 2.Pathologically confirmed prostate cancer and scheduled for elective RARP. 3.ASA classification I-III. 4.Voluntary participation and provision of signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Presence of clinically diagnosed chronic functional constipation, irritable bowel syndrome, gastroparesis, active inflammatory bowel disease, or any other known condition causing severe gastrointestinal motility disorders. 2.Presence of diseases that may significantly affect baseline inflammatory/immune status, including: active autoimmune diseases, acute infection within 1 month prior to screening, or long-term use of systemic immunosuppressive drugs. 3.Presence of conditions that may severely compromise the quality of upper abdominal ultrasound imaging, including: severe obesity; previous major upper abdominal surgery; massive ascites; or other anatomical abnormalities that, in the investigator's judgment, may prevent clear visualization of the standard gastric antrum section. 4.Presence of uncontrolled arrhythmias, second-degree or higher atrioventricular block, or presence of an implanted pacemaker/implantable cardioverter-defibrillator. Long-term regular use of medications known to significantly affect autonomic nervous system function or heart rate that cannot be paused preoperatively (see protocol appendix for specific drug list). 5.Presence of severe hepatic dysfunction or severe renal insufficiency. 6.Presence of auricular diseases, deformities, chronic infections, or active skin lesions at the stimulation target that may affect electrode contact or stimulation safety. 7.Presence of cognitive impairment, mental illness, or any other condition that, in the investigator's judgment, may render the patient unable to comply with the study.

Design outcomes

Primary

MeasureTime frame
Time to first postoperative flatus;

Secondary

MeasureTime frame
Time to first postoperative defecation;Incidence and severity of postoperative nausea and vomiting (PONV);Postoperative pain;Postoperative cumulative opioid consumption;Postoperative quality of recovery score;Postoperative length of hospital stay;Antral motility index;High-frequency power of heart rate variability;Interleukin-6;Interleukin-10;Tumor necrosis factor-alpha;Motilin;Acetylcholinesterase;Butyrylcholinesterase;Choline acetyltransferase;white blood cell;C-reactive protein;

Countries

China

Contacts

Public ContactMa Zhengliang; Wang Xiaoyi

Nanjing Drum Tower Hospital

13611586781@163.com+86 136 1158 6781

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026