Managing Colorectal Cancer Prevention Procedure Wait Lists During the COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Number of detection of neoplastic colon polyp
研究概览
简要总结
The main objective of this study is to offer and evaluate an interim triage approach for patients waiting for surveillance colonoscopies. This will reduce the waiting period and the psychological stressors for our patients and from a scientific point of view allow us to compare the yield of findings for each approach.
详细描述
This study will randomize patients (with low-risk findings in the initial colonoscopy) waiting for a surveillance colonoscopy into a follow-up with either FIT, CT colonography or colonoscopy. This approach will speed up the time for an exam for our patients and allow us to gather important data on the yield of significant findings when using FIT vs CT colonography vs colonoscopy for the surveillance exam.
All patients with positive FIT or CT colonography results will undergo subsequent colonoscopy. 300 patients will be randomized to 1:1:1 into 3 groups:
Group 1: patients will undergo Colonoscopy, findings will be documented and their participation in the study will end there. The findings of the colonoscopy will be addressed according to the institution's guidelines.
Group 2 will undergo fit testing if the fit test is positive: patients will have a subsequent colonoscopy within 3 months. Findings will be documented and participation in the study will end there. The findings of the colonoscopy will be addressed according to our institution's guidelines. If Fit test is negative patient will leave the study and will have a follow-up colonoscopy in one year.
Group 3 will have CT colonography. If CTC is positive: patients will have a subsequent colonoscopy within 3 months. Findings will be documented and participation in the study will end there. The findings of the colonoscopy will be addressed according to our institution's guidelines. If CTC is negative for polypoid lesions, the patient will leave the study and will have a follow-up 5 years after with a control colonoscopy.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •people with referral sheets for surveillance colonoscopies : meaning 3 or 5 years after the initial colonoscopy.
排除标准
- •known or suspected acute diverticulitis
- •ulcerative colitis
- •Crohn's disease
- •toxic megacolon
- •acute abdominal pain
- •familial polyposis syndrome
- •coagulopathy
- •poor general health (defined as an American Society of Anaesthesiologists class >3)
- •patients presenting for emergency colonoscopies
- •patients incapable of lying flat on their back for the duration of the CT colonography due CHF or other predispositions
- •patients with a personal history of CRC
- •patient undergoing colonoscopy for surveillance after EMR or ESD procedures
- •patients diagnosed with a CRC or a metastatic cancer
- •patients with a history of contrast allergies
- •Patients referred for polypectomy
结局指标
主要结局
Number of detection of neoplastic colon polyp
时间窗: 12 months
Number of patients with a neoplastic colon polyp detected during colonoscopy
Comparaison of neoplastic colon polyp number detected between CTC and colonoscopy
时间窗: 12 months
The number of neoplastic colon polyp detected with the CTC compare to the number of neoplastic colon polyp detected with colonoscopy
次要结局
- Number of patients on the list having a CTC and diagnosed with advanced neoplasia, non-advanced CR neoplasia, CR cancerous and precancerous lesions on colonoscopy(12 months)
- Number of patients on the list having a positive or negative FIT test or CTC and diagnosed with advanced neoplasia, non-advanced CR neoplasia, CR cancerous and precancerous lesions on colonoscopy(12 months)