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임상시험 NCT07320989은(는) 대장암 검사에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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메릴랜드 대학교, 볼티모어Impact of Chewing Gum on Bowel Preparation in Patients Undergoing Colonoscopy 100 예방
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07320989은(는) 대장암 검사에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2025년 12월 21일부터 참여 신청이 가능합니다. 100명의 참여자를 모집할 예정입니다. 메릴랜드 대학교, 볼티모어이(가) 진행하는 이 연구는 2025년 12월 31일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 1월 6일에 갱신되었습니다.
간단한 개요
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...더 보기
상세한 설명
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...더 보기
공식 제목
Impact of Chewing Gum on Bowel Preparation Quality and Tolerance in Patients Undergoing Colonoscopy With Split-Dose Bowel Preparation: A Randomized Controlled Trial
질환명
대장암 검사출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- HP-00115658
NCT 번호
실제 연구 시작일
2025-12-21
최신 업데이트 게시
2026-01-06
예상 연구 완료일
2025-12-31
계획된 등록 인원
100
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
Colonoscopy
Bowel Preparation
Chewing gum
Split-Dose PEG
Boston Bowel Preparation Scale
Patient Tolerance
Randomized Controlled Trial
Bowel Preparation
Chewing gum
Split-Dose PEG
Boston Bowel Preparation Scale
Patient Tolerance
Randomized Controlled Trial
주요 목적
예방
설계 할당
무작위배정
중재 모델
요인설계
맹검 (마스킹)
단일맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Chewing 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...더 보기 | 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...더 보기 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. |
활성 대조군Standard 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. |
실험적Chewing 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...더 보기 | 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...더 보기 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. |
활성 대조군Standard 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. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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). |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
45 Years
참여 가능한 성별
전체
- 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
메릴랜드 대학교, 볼티모어연구 책임자
Ekta Gupta, 책임연구자, Professor of Gastroenterology, University of Maryland, Baltimore
연구 대표 연락처
연락처: Ekta Gupta, MD, (410) 225-8301, [email protected]
1 1개국에 임상시험 장소
Maryland
UMMC Midtown - Outpatient Endoscopy Center, Towson, Maryland, 21204, United States
Ekta Gupta, MD, 연락처, 410-698-6432, [email protected]