Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial Group 1 | Experimental | 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. |
|
| Trial Group 2 | Experimental | 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. |
|
| Control Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intestinal pacing + ST36 acupoint stimulation | Other | The day before the examination began a real stimulation treatment, namely, intestinal pacing (① location: positive pole placed on the navel (the line between the raphe and navel) 1 to 2 cm, the negative pole in the raphe and the navel line at the midpoint of the right 4 to 10 cm; ② parameters: the intestinal frequency: 2.4-3.7 cpm, the first time the frequency of use of 3.0 cpm, treatment of the base wave intensity of 0-15 gears, the first time to use the intestinal treatment intensity of 10 gears) , acupoint stimulation (① location: treatment sheet attached to both legs ST36 acupoints, i.e., four transverse fingers below the eye of the outer knee, 4 transverse fingers next to the tibia; ② parameters: the first use of acupoint intensity 30%, to the patient's self-conscious stimulation points have a slight pinprick sensation, lifting sensation, warm sensation is appropriate). |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel Preparedness Score | Using the Boston Bowel Preparation Scale(BBPS) | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Polyp detection rate | Day 2 | |
| Adenoma detection rate | Day 2 | |
| Adverse reactions |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lan Zhong | Contact | +86 13162099450 | lanzhong@tongji.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Shanghai | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| ID | Term |
|---|---|
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sham acupoint intestinal pacing + sham ST36 acupoint stimulation | Other | A sham stimulation treatment was started one day before the examination, i.e., intestinal pacing treatment with the electrode pads offset to the lumbar side to stimulate the sham acupoints, and acupoint stimulation with the treatment pads applied to the ST36 acupoints but without turning on the current switch. |
|
collected using a questionnaire
| Baseline and Day 2 |
| Complete Blood Count | Baseline and Day 2 |
| C-Reactive Protein | Baseline and Day 2 |
| Inflammatory Cytokines(TNF-α,IL-6,IL-10……) | Baseline and Day 2 |
| Gastrointestinal Hormones (Pancreatic Polypeptide, Motilin, Vasoactive Intestinal Peptide……) | Baseline and Day 2 |