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
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
Treatments tested in this trial
- Intestinal pacing + ST36 acupoint stimulation
- Sham acupoint intestinal pacing + sham ST36 acupoint stimulation
Treatment groups
270 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov