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临床试验/NCT07456007
NCT07456007已完成不适用

A Patient Blinded, Randomized, Controlled Trial Comparing Right Colon Adenoma Detection Rate in Colonoscopy Using Right Colon Water Exchange and Traditional Air Insufflation

Dalin Tzu Chi General Hospital1 个研究点 分布在 1 个国家目标入组 414 人开始时间: 2020年6月9日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
414
试验地点
1
主要终点
adenoma detection rate in proximal colon

研究概览

简要总结

Although colonoscopy is currently regarded as the gold standard to detect and prevent colorectal cancer (CRC) but post-colonoscopy CRCs (interval cancer, IC) still occur. Recent studies demonstrated that protection by colonoscopy against right-sided colon cancer was lower than that attained in the left colon. Adenoma detection rate (ADR) has been correlated with IC - each 1 % increase in ADR is associated with 3% decrease in the risk of ICs. Hopefully, innovations that improve right colon ADR would reduce the right colon IC. Insertion water exchange (WE), characterized by infusing water to guide the advance of the colonoscope in an airless lumen with its removal mainly during insertion. WE has been shown to improve the overall and right colon ADR compared to traditional air insufflation (Air). Several plausible causes have been proposed to explain the enhanced ADR by WE, including decreased multitasking related distraction, improved bowel cleanness, and flat polyps appearing less flatten and floating up in water Therefore, the adoption of WE in the right colon might be especially beneficial. In addition, WE has been criticized for prolonged insertion time, about 3-5 minutes longer than Air to reach the cecum and required a learning curve of about 50 to 100 cases.In this study, we devise a right colon WE method (RCWE), in which Air will be used to intubate to the hepatic flexure, followed by WE in the right colon. We test the hypothesis that RCWE would increase the right colon ADR without prolonging the insertion time. Consecutive patients undergoing screening, surveillance, or diagnostic examinations performed by participating endoscopists will be stratified for enrollment. Patients will be randomized in a 1:1 ratio (n=207 per group) to either the AI or RCWE group. Demographic data (age, gender, height, and weight), indications for colonoscopy, history of abdominal or pelvic surgery, constipation and chronic use of laxatives will be ascertained before colonoscopy. Quality of bowel preparation, cecal intubation time, withdrawal time, total procedure time, use of abdominal compression, need for change of position, presence and location of polyps and reasons for incomplete colonoscopy will be recorded. In addition, the right colon (from the hepatic flexure to cecum) insertion time and withdrawal time and infused and suction water amount will be recorded separately.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 40 to 80 years.
  • Patients undergoing screening, surveillance, or diagnostic colonoscopy.
  • Colonoscopy performed by participating endoscopists.
  • Ability to provide written informed consent.

排除标准

  • Inability or unwillingness to provide informed consent.
  • Age < 40 years or > 80 years.
  • History of colorectal surgery (e.g., partial colectomy).
  • Known or suspected colorectal cancer.
  • Known inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease).
  • Planned therapeutic colonoscopy (e.g., polypectomy).
  • Inadequate bowel preparation.
  • Known or suspected colonic obstruction or severe stricture.
  • Massive ascites.
  • Severe comorbid conditions (e.g., renal failure).
  • Emergency colonoscopy.

研究组 & 干预措施

Right colon water exchange group

Experimental

Air insufflation was used to advance the colonoscope to the hepatic flexure, where the insertion method was switched to water exchange (WE) to reach the cecum. This predefined transition was designed to specifically evaluate the effect of WE on right-sided colon adenoma detection.

干预措施: Right colon water exchange (Behavioral)

Air insufflation group

Active Comparator

Cecal intubation was achieved using conventional air insufflation.

干预措施: Air nsufflation (Behavioral)

结局指标

主要结局

adenoma detection rate in proximal colon

时间窗: one week

The proportion of patients with the presence of adenoma in the proximal colon.

次要结局

  • adenoma detection rate(one week)

研究者

发起方
Dalin Tzu Chi General Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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