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Effect of percutaneous auricular vagus nerve stimulation on postoperative bowel function in patients with Crohn's disease

Effect of percutaneous auricular vagus nerve stimulation on postoperative bowel function in patients with Crohn's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088010
Enrollment
Unknown
Registered
2024-08-08
Start date
2024-08-10
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

Crohn's disease

Interventions

stimulus package:The stimulation group received stimulation of the right auricular boat at a frequency of 25 Hz and a pulse width of 200 µs, 30 s on/30 s off, for 5 consecutive days (the first stimula
Pseudostimulus group:The Pseudostimulus group received the same cycle of treatment. The sham stimulus was placed on the right side of the auricular boat via an electrode, and the electrical stimulatio
frequency: 25 Hz), which would be initiated at 10 mA, was gradually increased in stimulation intensity until a "tingling sensation" was reported by the subject within 20 seconds of its initiation, and

Sponsors

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis of CD is confirmed according to the consensus opinion on the diagnosis and treatment of IBD and is treated by elective laparoscopic surgery under general anesthesia. 2. Aged 18 to 65 years old, inclusive. 3. Be able to understand the study process and the use of various assessment scales, and be able to communicate effectively with the study staff. 4. American Society of Anesthesiologists (ASA) grade 1-3. 5. Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. A history of conditions associated with autonomic dysfunction (e.g., peripheral neuropathy, diabetes mellitus, vagotomy, abnormal thyroid function, amyloidosis, asthma, heart failure, renal insufficiency, alcoholism) 2. Suffering from dermatitis of the right auricle. 3. Taking medications that affect vagal function (e.g., anticholinergics, antiarrhythmics, alpha or beta blockers). 4. A history of prior gastrointestinal surgery. 5. A history of severe cardiac, pulmonary, or renal disease. 6. A combination of malignant tumors. 7. Inability to cooperate with evaluations 8. Seizures or recurrent syncope within the last 5 years. 9. A history of transient ischemic attack or cerebrovascular accident. 10. Received vagus nerve stimulation or acupuncture within 1 month prior to the study. 11. Vulnerable groups, including people with mental illness, cognitive impairment, critically ill patients, pregnant women, illiterate people, etc.

Design outcomes

Primary

MeasureTime frame
Time of subject's first postoperative defecation;

Secondary

MeasureTime frame
Basic information;Surgical situation;Numerical rating scale (NRS) Pain Score;Quality of Recovery (QOR) 15 scale;Number of bowel sounds at 1, 3, and 5 days after surgery;Inflammation indicators;Incidence of postoperative nausea and vomiting;Postoperative complication rate;Time to first postoperative oral feeding (days);Length of hospitalization (days);

Countries

China

Contacts

Public ContactGang Chen

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

chengang120@zju.edu.cn+86 137 5711 8681

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026