Intestinal Polyps
Conditions
Keywords
Bowel Preparation, Noninvasive electrical neuromodulation
Brief summary
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.
Interventions
OTHERIntestinal pacing + ST36 acupoint stimulation
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).
OTHERSham acupoint intestinal pacing + sham ST36 acupoint stimulation
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.
Sponsors
Shanghai East Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel Preparedness Score | Day 2 | Using the Boston Bowel Preparation Scale(BBPS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | Day 2 | — |
| Adverse reactions | Baseline and Day 2 | collected using a questionnaire |
| Complete Blood Count | Baseline and Day 2 | — |
| Polyp detection rate | 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 | — |
| C-Reactive Protein | Baseline and Day 2 | — |
Countries
China
Contacts
Primary ContactLan Zhong
Outcome results
None listed