رادار التجارب AI | ||
|---|---|---|
حالة التجربة السريرية NCT07395492 لـ Bowel Preparation Solution هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
App-Based Education and Low-Residue Diet for Colonoscopy Preparation ٤٢٠ عشوائية نظام غذائي
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07395492 هي دراسة تدخُّلية لـBowel Preparation Solution وهي لم يبدأ القبول بعد. من المقرر أن يبدأ التسجيل في ١٢ رمضان ١٤٤٧ هـ لتجنيد ٤٢٠ مشاركًا. يقودها Chang Gung Memorial Hospital، ومن المتوقع اكتمالها بحلول ١٠ جمادى الأولى ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢١ شعبان ١٤٤٧ هـ.
الملخص
This prospective, randomized, evaluator-blind, parallel-group trial is designed to objectively compare the effectiveness of Advanced Bowel Preparation versus Traditional Bowel Preparation in patients undergoing colonoscopy. In this study, "naive patients" are defined as individuals who have never used Bowklean® as a bowel cleansing agent, or those who may have previously used other bowel preparation regimens but have...عرض المزيد
وصف مفصل
Bowel preparation is a important task for colonoscopy examination. Studies have demonstrated that using smartphone apps can improve patient compliance and the quality of bowel cleansing. Additionally, the use of prepackaged low residue diet (PLD) has become increasingly common. PLD are designed to minimize undigested food residue in the gut, facilitating a cleaner colon for procedures like colonoscopy. Implementing P...عرض المزيد
العنوان الرسمي
Impact of App-Based Education and Low-Residue Diet Approaches on Colonoscopy Preparation in Naive Patients: A Randomized, Evaluator-Blind Controlled Trial
الحالات الطبية
Bowel Preparation Solutionمعرّفات دراسة أخرى
- 202501149B0
NCT معرّف
تاريخ البدء (فعلي)
2026-03-01
آخر تحديث مُنشور
2026-02-09
تاريخ الاكتمال (المقدر)
2026-10-21
عدد المشاركين المخطط لهم
٤٢٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
لم يبدأ القبول بعد
الكلمات الرئيسية
Bowklean
Bowel preparation
Low-residue diet
boston bowel preparation scale
Bowel preparation
Low-residue diet
boston bowel preparation scale
الغرض الأساسي
تشخيصي
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
أحادي
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
بدون تدخلTraditional Bowel Preparation The Traditional Bowel Preparation approach consists of standard paper-based educational handouts and self-managed low-residue dietary restrictions. | غ/م |
تجريبيةAdvanced Bowel Preparation Advanced Bowel Preparation integrates a smartphone-based educational app (Tian Tian Yi Chi go, developed by UIC Corp.) with a Prepackaged Low-Residue Diet (PLD). | Tian Tian Yi Chi go APP (developed by UIC Corp) Bowl preparation educational app Prepackaged Low-Residue Diet Prepackaged Low-Residue Diet |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Percentage of subjects that achieve adequate cleansing | The percentage of subjects that achieve adequate cleansing (score ≧ 6) in the Boston Bowel Preparation Scale (BBPS) | Day1 |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
The percentage of subjects that achieve excellent cleansing | (score ≧ 8) in the Boston Bowel Preparation Scale (BBPS). | Day1 |
Mean score in different colon segments | right, transverse, left colon segmental subscore, which are assessed with the BBPS. | Day1 |
Adenoma Detection Rate (ADR) | Proportion of patients in whom at least one adenoma is detected during the colonoscopy. | Day14 |
Sessile Serrated Polyp (SSP) Detection Rate | Proportion of patients in whom at least one SSP is detected during the colonoscopy. | Day14 |
Patient Satisfaction | Satisfaction will be evaluated in three subcategories through a questionnaire:
1. Bowel cleansing agent: Assessing the experience and acceptability of using Bowklean.
2. Dietary restrictions: Evaluating satisfaction with the assigned low-residue dietary approach (PLD or self-prepared).
3. APP Satisfaction: For groups assigned to APP utilization, assessing the APP's ease of use, functionality, and perceived utility. | Day1 |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
- Male or female 18 to 75 years of age.
- Bowklean naive patient with no bowel preparation in 3 years.
- The subject is scheduled for a colonoscopy.
- Ability to complete the entire procedure and to comply with study instructions.
- Willingness and ability to provide signed informed consent.
1. Patients who are unsuitable for Bowklean use due to known contraindications, including but not limited to:
- Allergies or hypersensitivity to Bowklean or its ingredients.
- Severe gastrointestinal conditions (e.g., obstruction, perforation).
- Renal impairment or electrolyte imbalances (e.g., severe hyponatremia).
- Gastrointestinal surgery affects bowel preparation. 2. Patients deemed medically unsuitable for colonoscopy by the physician. 3. Cognitive, language, or other barriers that prevent completion of the questionnaire.
4. Non-compliance with the bowel preparation protocol or inability to follow dietary restrictions (e.g., Prepackaged low residue diet, PLD).
5. Inability to use or access the mobile APP (e.g., no smartphone, unfamiliarity with APP operations, or technical limitations).
6. Participation in other clinical trials.
Chang Gung Memorial HospitalUniversal Integrated Corp.الجهة المسؤولة عن الدراسة
Chen-Ming Hsu, المحقق الرئيسي, Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital
لا توجد بيانات اتصال.