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A non-inferiority randomized controlled exploratory trial of percutaneous auricular vagus nerve electrical stimulation combined with a reduced-dose PEG regimen for optimizing bowel preparation before colonoscopy

A non-inferiority randomized controlled exploratory trial of percutaneous auricular vagus nerve electrical stimulation combined with a reduced-dose PEG regimen for optimizing bowel preparation before colonoscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116030
Enrollment
Unknown
Registered
2026-01-04
Start date
2026-01-04
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

None

Interventions

3L PEG Group:According to the conventional 3L PEG regimen in the Expert Consensus on Bowel Preparation for Colonoscopy (2023, Guangzhou): 1L of polyethylene glycol (PEG) electrolyte powder shall be ta
2L of PEG electrolyte powder shall be taken orally 4-6 hours before the colonoscopy, and shall be completed within 1 hour. All medication administrations shall be performed under the bedside guidance
taVNS+2.5L PEG Group:At 20:00 on the night before the colonoscopy, participants will receive transcutaneous auricular vagus nerve stimulation (taVNS) for 30 minutes concurrently with oral administrati
4-6 hours before the colonoscopy, participants will take 1.5L PEG electrolyte powder orally, and taVNS intervention will be initiated concurrently with the start of PEG administration for 30 minutes
an additional 30-minute taVNS intervention will be performed 4 hours after the completion of PEG administration. All three interventions will be conducted under the bedside guidance of researchers.

Sponsors

Affiliated Hospital of Nanjing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-70 years, regardless of gender; 2.Presence of colorectal polyps confirmed by a colonoscopy report from a Grade A Class II or above hospital within the past 6 months; 3.Planned to undergo colonoscopic treatment in accordance with clinical guidelines; 4.American Society of Anesthesiologists (ASA) Physical Status Classification Grade I-III, with physical condition tolerable to colonoscopy and bowel preparation; 5.Clear consciousness and normal cognitive function, able to understand the study procedures and sign the informed consent form (ICF); 6.Willing and able to strictly comply with all requirements of the study protocol.

Exclusion criteria

Exclusion criteria: 1.History of colorectal surgery (e.g., colectomy, ileal pouch surgery, etc.); 2.Presence of diseases severely affecting gastrointestinal function (e.g., active inflammatory bowel disease, refractory constipation, intestinal obstruction, etc.); 3.Severe, uncontrolled cardiovascular and cerebrovascular, hepatic, renal, or respiratory diseases; 4.Local infection, damage, or deformity of the auricle, making it unfit for wearing transcutaneous auricular vagus nerve stimulation (taVNS) devices; 5.Implanted cardiac pacemakers, defibrillators, or other electronic implantable medical devices in the body (to avoid electrical stimulation interference from taVNS); 6.Diseases associated with increased vagal excitability or contraindications to vagus nerve stimulation (e.g., severe bradycardia, carotid sinus hypersensitivity syndrome, etc.); 7.Past history of neurological or psychiatric diseases such as epilepsy or depression, and currently receiving relevant treatment (to avoid interference from the original indications of VNS); 8.Long-term use of drugs that may significantly affect gastrointestinal motility (e.g., opioid analgesics, anticholinergic drugs, etc.), and inability to discontinue the drugs as required before the examination; 9.Known allergy to the components of the laxatives used in the study; 10.Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Boston Bowel Preparation Scale (BBPS);

Secondary

MeasureTime frame
Air Bubble Scale (ABS);Number of Detected Colorectal Polyps and Polyp Detection Qualification Rate;Abdominal Distension;Nausea;Vomiting;Complete Compliance Rate with the Study Protocol;Time to First Flatus Post-Procedure (TFF);Patient Preference and Future Willingness to Choose;

Countries

China

Contacts

Public ContactLi Yang

Affiliated Hospital of Nanjing University of Chinese Medicine

ayly0550@163.com+86 1855188008

Outcome results

None listed

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