Effect of Non-invasive Neuromodulation on the Quality of Intestinal Cleansing

Tongji University

Status: Not yet enrolling

Conditions: Intestinal Polyps

Treatments: Other: Sham acupoint intestinal pacing + sham ST36 acupoint stimulation; Other: Intestinal pacing + ST36 acupoint stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07290816

2023YS-077 Amendment 1

Details and patient eligibility

About

To clarify whether non-invasive neuromodulation for assisted bowel preparation can improve the quality of bowel preparation, to explore the possible mechanisms by which TEA improves the quality of bowel preparation, and to assess its safety, as well as subjects' tolerance, compliance and satisfaction.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 78 years of age, male or female;
• Intended to undergo diagnostic, screening, or surveillance colonoscopy;
• Signed written informed consent.

Exclusion criteria

• Severe cardiac, cerebral, pulmonary, or renal complications or a history of acute cardiac infarction within six months;
• High risk factors for bowel preparation such as history of colon surgery, BMI ≥ 28, inflammatory bowel disease, constipation (less than 3 bowel movements in the last week, and with straining to defecate, with hard stools and small amount of stools) or bowel obstruction;
• High suspicion of colorectal cancer by auxiliary examination or early warning signs and symptoms of colorectal cancer: blood in stool, black stool, unexplained anemia, significant weight loss, abdominal mass and positive rectal fingerprinting;
• The presence of surgical incisions or scars in the area where the electrostimulation treatment tablets are pasted, or near the ST36 acupoints on both legs;
• Are participating in other clinical observation trials or have participated in other clinical trials within 30 days.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

270 participants in 3 patient groups

Trial Group 1

Experimental group

Description:

Bowel pacing (specific location and parameters) and ST36 acupoint stimulation (specific location and intensity) were used the day before the examination; 2L of PEG was taken the night before the examination and on the day of the examination, and 30 ml of simethicone was taken orally immediately after all of the 4L of PEG had been taken. Colonoscopy was completed within 2-6 hours after bowel preparation was completed.

Treatment:

Other: Intestinal pacing + ST36 acupoint stimulation

Trial Group 2

Experimental group

Description:

Sham acupoint bowel pacing and sham ST36 acupoint stimulation were used the day before the examination (electrode pads were offset and current switch was not turned on; 2L of PEG was taken the night before and on the day of the examination, respectively, and 30 ml of simethicone was taken orally immediately after all of the 4L of PEG had been taken. Colonoscopy was completed within 2-6 hours after bowel preparation was completed.

Treatment:

Other: Sham acupoint intestinal pacing + sham ST36 acupoint stimulation

Control Group

No Intervention group

Description:

Only conventional treatment was used, with 2 portions of 2000 ml PEG taken with fasting starting at 19:00 pm the night before the examination and required to be taken within 2 hours. On the day of the examination, 2 doses of 2000 ml of PEG were taken orally starting 3-5 hours before the colonoscopy procedure, which was required to be completed within 2 hours, and 30 ml of simethicone was taken orally as soon as the subject had finished taking the laxative, and all bowel preparations had to be completed more than 2 hours and less than 6 hours before the colonoscopy procedure, and if the time limit was exceeded the subject was excluded from the study.