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

Официальное название

Effect of Non-invasive Neuromodulation on the Quality of Bowel Cleansing: a Randomized, Controlled, Double-blind Clinical Study

Обзор

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.

Вмешательства

• Другое Intestinal 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 gea
• Другое Sham 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.

Первичные конечные точки

• Bowel Preparedness Score [Срок оценки: Day 2]

Вторичные конечные точки (7)

• Polyp detection rate [Срок оценки: Day 2]
• Adenoma detection rate [Срок оценки: Day 2]
• Adverse reactions [Срок оценки: Baseline and Day 2]
• Complete Blood Count [Срок оценки: Baseline and Day 2]
• C-Reactive Protein [Срок оценки: Baseline and Day 2]
• Inflammatory Cytokines(TNF-α，IL-6，IL-10……) [Срок оценки: Baseline and Day 2]
• Gastrointestinal Hormones (Pancreatic Polypeptide, Motilin, Vasoactive Intestinal Peptide……) [Срок оценки: Baseline and Day 2]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai East Hospital — Шанхай

Идентификаторы

NCT: NCT07290816 · 2023YS-077 Amendment 1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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