Health TrialsbyHealthPanel

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

ConditionIntestinal Polyps
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-78
SponsorShanghai East Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 to 78 years of age, male or female;

Intended to undergo diagnostic, screening, or surveillance colonoscopy;

Signed written informed consent.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intestinal pacing + ST36 acupoint stimulation

    Other intervention

    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).

  • Sham acupoint intestinal pacing + sham ST36 acupoint stimulation

    Other intervention

    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.

Treatment groups

270 Participants
are divided into 3 treatment groups
Group A: Trial Group 1Experimental treatment 1 intervention
Group B: Trial Group 2Experimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Bowel Preparedness Score

Using the Boston Bowel Preparation Scale(BBPS)

Time frame
Day 2

Secondary outcomes

1

Polyp detection rate

Time frame
Day 2
2

Adenoma detection rate

Time frame
Day 2
3

Adverse reactions

collected using a questionnaire

Time frame
Baseline and Day 2
4

Complete Blood Count

Time frame
Baseline and Day 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai East Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: