رادار التجارب AI
حالة التجربة السريرية NCT07320989 لـ فحص سرطان القولون 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
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Impact of Chewing Gum on Bowel Preparation in Patients Undergoing Colonoscopy ١٠٠ وقاية

لم يبدأ القبول بعد
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 NCT07320989 هي دراسة تدخُّلية لـفحص سرطان القولون وهي لم يبدأ القبول بعد. من المقرر أن يبدأ التسجيل في ١ رجب ١٤٤٧ هـ لتجنيد ١٠٠ مشاركًا. يقودها جامعة ميريلاند، بالتيمور، ومن المتوقع اكتمالها بحلول ١١ رجب ١٤٤٧ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٧ رجب ١٤٤٧ هـ.
الملخص
Colorectal cancer is the second leading cause of cancer deaths that could be prevented in the United States. Colonoscopy is the best test for finding and removing polyps before they turn into cancer. However, many people are hesitant to have a colonoscopy because of the bowel preparation. The preparation can be difficult to tolerate, with patients often struggling to finish it due to the taste, volume, or side effect...عرض المزيد
وصف مفصل
Background and Rationale Colorectal cancer (CRC) remains the second leading cause of preventable cancer-related death in the United States, with approximately 150,000 new cases and 50,000 deaths annually. Colonoscopy is the gold-standard screening modality for CRC because it allows both detection and removal of precancerous lesions within the same procedure. However, the success of colonoscopy depends heavily on adeq...عرض المزيد
العنوان الرسمي

Impact of Chewing Gum on Bowel Preparation Quality and Tolerance in Patients Undergoing Colonoscopy With Split-Dose Bowel Preparation: A Randomized Controlled Trial

الحالات الطبية
فحص سرطان القولون
المنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:
معرّفات دراسة أخرى
  • HP-00115658
NCT معرّف
NCT07320989
تاريخ البدء (فعلي)
2025-12-21
آخر تحديث مُنشور
2026-01-06
تاريخ الاكتمال (المقدر)
2025-12-31
عدد المشاركين المخطط لهم
١٠٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
لم يبدأ القبول بعد
الكلمات الرئيسية
Colonoscopy
Bowel Preparation
Chewing gum
Split-Dose PEG
Boston Bowel Preparation Scale
Patient Tolerance
Randomized Controlled Trial
الغرض الأساسي
وقاية
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم العاملي
التعمية
أحادي
مجموعات/التدخلات
مجموعة المشاركين/الذراعالتدخل/العلاج
تجريبيةChewing Gum During Bowel Preparation (2L PEG-ELP)
Participants randomized to the experimental arm will chew one piece of sugar-free gum for approximately 15-20 minutes, 30 minutes before starting the first dose of split-dose bowel preparation and again 30 minutes after the second dose. The gum is sugar-free and non-medicated. Participants will be instructed not to swallow the gum and to discontinue chewing if they experience discomfort. All participants will receiv...عرض المزيد
Chewing Sugar-Free Gum During Bowel Preparation
Participants randomized to the intervention arm will chew one piece of sugar-free gum for approximately 15-20 minutes, 30 minutes before the first dose of split-dose polyethylene glycol (PEG) bowel preparation and again 30 minutes after completing the second dose. The gum-chewing activity is intended to improve tolerance and satisfaction with the bowel preparation process through cephalic-vagal stimulation ("sham fe...عرض المزيد
Standard Bowel Prep (2L PEG-ELP)
Participants in this comparator arm will follow standard split-dose polyethylene glycol (PEG) bowel preparation (either 4L PEG or 2L PEG + ascorbate, prescribed per clinical indication) without gum chewing before or after the preparation. This represents the standard-of-care approach currently used for colonoscopy preparation at the study site.
مقارن نشطStandard Bowel Preparation 4L (No Gum)
Participants in the control arm will undergo standard split-dose bowel preparation (4L PEG) according to clinical indication, without chewing gum before or after the preparation. Endoscopists will be blinded to participant group assignment.
Standard Bowel Prep
Participants in this comparator arm will follow standard split-dose polyethylene glycol (PEG) bowel preparation (4L PEG, prescribed per clinical indication) without gum chewing before or after the preparation. This represents the standard-of-care approach currently used for colonoscopy preparation at the study site.
تجريبيةChewing Gum During 4L Bowel Preparation
Arm Description: Participants randomized to the experimental arm will chew one piece of sugar-free gum for approximately 15-20 minutes, 30 minutes before starting the first dose of split-dose bowel preparation and again 30 minutes after the second dose. The gum is sugar-free and non-medicated. Participants will be instructed not to swallow the gum and to discontinue chewing if they experience discomfort. All particip...عرض المزيد
Chewing Sugar-Free Gum During Bowel Preparation
Participants randomized to the intervention arm will chew one piece of sugar-free gum for approximately 15-20 minutes, 30 minutes before the first dose of split-dose polyethylene glycol (PEG) bowel preparation and again 30 minutes after completing the second dose. The gum-chewing activity is intended to improve tolerance and satisfaction with the bowel preparation process through cephalic-vagal stimulation ("sham fe...عرض المزيد
Standard Bowel Prep
Participants in this comparator arm will follow standard split-dose polyethylene glycol (PEG) bowel preparation (4L PEG, prescribed per clinical indication) without gum chewing before or after the preparation. This represents the standard-of-care approach currently used for colonoscopy preparation at the study site.
مقارن نشطStandard Bowel Preparation 2L PEG-ELP (No Gum)
Arm Description: Participants in the control arm will undergo standard split-dose bowel preparation (2L PEG + ascorbate) according to clinical indication, without chewing gum before or after the preparation. Endoscopists will be blinded to participant group assignment.
Standard Bowel Prep (2L PEG-ELP)
Participants in this comparator arm will follow standard split-dose polyethylene glycol (PEG) bowel preparation (either 4L PEG or 2L PEG + ascorbate, prescribed per clinical indication) without gum chewing before or after the preparation. This represents the standard-of-care approach currently used for colonoscopy preparation at the study site.
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
Bowel cleansing quality (BBPS total score)
Boston Bowel Preparation Scale (0-9; sum of right, transverse, left colon segment scores) assessed by the blinded endoscopist. Higher scores indicate better cleansing.
Day of colonoscopy (intra-procedure assessment, immediately prior to withdrawal).
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
Patient tolerance
Global tolerance/symptom score (Likert or VAS) for nausea, bloating, cramps, and overall ease of prep recorded during routine pre-procedure nursing intake.
Day of colonoscopy (pre-procedure)
Patient satisfaction
Single-item satisfaction rating (Likert) with the bowel preparation process, recorded by nursing staff.
Day of colonoscopy (pre-procedure)
Prep completion rate
Proportion completing 100% of prescribed split-dose regimen vs partial/unknown, per intake documentation.
Day of colonoscopy (pre-procedure)
Willingness to repeat
Willingness to repeat the same bowel prep in the future (yes/no or Likert).
Day of colonoscopy (pre-procedure)
Segmental Boston Bowel Preparation Scale (BPPS) Scores
Right, transverse, and left colon BBPS segment scores. Boston Bowel Preparation Scale (0-9; sum of right, transverse, left colon segment scores) assessed by the blinded endoscopist. Higher scores indicate better cleansing.
Day of colonoscopy (intra-procedure)
Cecal intubation rate
Successful cecal intubation (yes/no) per standard endoscopy report.
Day of colonoscopy (intra-procedure)
Adenoma detection rate (ADR)
Proportion of colonoscopies with ≥1 histologically confirmed adenoma (if pathology recorded as part of usual care).
Day of colonoscopy to 2 weeks post-procedure (to allow routine pathology posting)
Procedure metrics
Withdrawal time and total procedure duration (minutes).
Day of colonoscopy
Adverse events
Immediate procedure-day AEs (e.g., gum-related issues reported at intake; standard colonoscopy AEs captured in recovery notes).
Day of colonoscopy
مساعد المشاركة
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
45 Years
الجنس المؤهل
الكل
  • Age 45-75 years
  • Scheduled for elective outpatient colonoscopy
  • Able to provide informed consent

  • Prior major abdominal surgery (excluding appendectomy or cholecystectomy)
  • Pregnancy
  • Cognitive impairment
  • Ward of the state
  • Known allergy to PEG or gum components
  • Current use of GI prokinetics
  • Known temporomandibular joint (TMJ) disorder or difficulty chewing/swallowing
University of Maryland, Baltimore logoجامعة ميريلاند، بالتيمور
الجهة المسؤولة عن الدراسة
Ekta Gupta, المحقق الرئيسي, Professor of Gastroenterology, University of Maryland, Baltimore
جهة اتصال مركزية للدراسة
جهة اتصال: Ekta Gupta, MD, (410) 225-8301, [email protected]
1 مواقع الدراسة في 1 بلدان

Maryland

UMMC Midtown - Outpatient Endoscopy Center, Towson, Maryland, 21204, United States
Ekta Gupta, MD, جهة اتصال, 410-698-6432, [email protected]