- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01035775
Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?
연구 개요
상세 설명
Background: Colonoscopy is not a perfect test. It misses a substantial number of neoplastic lesions and has some risk of missing cancer. Nearly all work on detection during colonoscopy has focused on the withdrawal phase of the examination. Thus, colonoscopy is typically performed by rapidly passing the instrument through the loops and bends of the colon in order to reach the tip of the cecum, and then performing a slow withdrawal in which the tip of the instrument is systematically deflected, and the mucosa is careful cleaned and suctioned, to expose all of the colonic mucosa for viewing.
Many experienced colonoscopists recognize that small polyps seen incidentally but not removed during insertion are sometimes quite difficult to find during withdrawal. The reason for this observation is probably because the colon is in a very different anatomical conformation during endoscope insertion and withdrawal. During insertion, the colon is in its natural conformation in which the sigmoid and transverse colon has several sharp bends or flexures, and the overall length has not yet been shortened. In this phase, the colon is often significantly stretched because of the formation of loops and bends in the colonoscope. This greatly affects the conformation of the colonic wall visualized proximal to the instrument tip. During withdrawal, the colon is shortened and pleated over the colonoscope, with successive regions of the colon being inspected as they slip off the end of the instrument. Thus, segments of visualized colon are often much straighter during withdrawal than during insertion. The insertion and withdrawal phases, therefore, expose somewhat different sections of the mucosal surface to the colonoscope and inspection on insertion and withdrawal are, quite possibly, complementary.
Aims: This randomized, controlled trial will compare the additional effect on the rate of adenoma detection of mucosal inspection during colonoscope insertion, with inspection during instrument withdrawal, in patients undergoing colonoscopy for colorectal cancer screening or surveillance.
Study procedure: In this study, we plan to investigate whether a specified interval of inspection during insertion can increase overall adenoma detection. We will conduct a randomized controlled trial, in which patients will be randomized to have all of the inspection performed during the withdrawal phase (as is usual care) versus having several minutes of examination specifically devoted to inspection during insertion.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
Indiana
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Indianapolis, Indiana, 미국, 46202
- Indiana University Hospital
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Indianapolis, Indiana, 미국, 46280
- Beltway Surgery Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age ≥ 50 years
- Patients undergoing colonoscopy for screening or surveillance indications
Exclusion Criteria:
- Previous surgical resection of all or part of the colon.
- Inability to give informed consent.
- Ulcerative colitis or Crohn's disease.
- Polyposis syndrome or Lynch syndrome (HNPCC)
- Any comorbid condition which the investigator deems would put the patient at increased risk from a slightly prolonged procedure
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Insertion
Inspection on colonoscope insertion in addition to inspection during withdrawal from the cecum.
|
The colonic mucosa will be inspected for lesions during insertion of the instrument, and during withdrawal of the instrument.
|
|
활성 비교기: Withdrawal
Inspection during withdrawal (usual care) without deliberate inspection during insertion.
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The colonic mucosa will be inspected for lesions only during withdrawal of the instrument from the cecum.
The instrument will be inserted to the cecum without deliberate inspection.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Adenoma detection rate
기간: During colonoscopy
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During colonoscopy
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Sedation dose
기간: During colonoscopy
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During colonoscopy
|
|
Post procedural pain scores
기간: Within 1 hour of colonoscopy
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Within 1 hour of colonoscopy
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Proportion of patients with at least one adenoma detected
기간: During colonoscopy
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During colonoscopy
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공동 작업자 및 조사자
수사관
- 수석 연구원: Douglas K Rex, M.D., Indiana University School of Medicine
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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