Impact of Real-time Notification of Colonoscopic Optical Diagnosis on Patients' Anxiety and Depression After Polypectomy: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Proportion of definite anxiety cases
研究概览
简要总结
The accuracy of endoscopic optical diagnosis for colorectal polyps has been approaching histological diagnosis after implementation of image enhancement endoscopic technologies. The real-time notification of possible nature of resected polyp after colonoscopy is expected to reduce the anxiety and depression level of the patients before the availability of histological diagnosis and improve their quality of life. We designed and conducted a randomized control trial to confirm this hypothesis.
详细描述
This is a single center, open-label, prospective and parallel randomized controlled trial. This study planning to recruit outpatients from the age of 40 to 79 who are scheduled to undergo sedated colonoscopy. Once eligible subjects were diagnosed of colorectal polyps during colonoscopy and received polypectomy, they will be randomized into "ordinary care group (explained at next scheduled clinic)" and "real-time notification group (explained immediately after colonoscopy)". The level of anxiety, depression of the two groups will be measured by using the Taiwan version questionnaire of Hospital Anxiety and Depression Scale (HADS) right before the next scheduled clinic for histological results and compared the difference between the two groups.This study is expected to determine the impact of real-time notification of colonoscopic optical diagnosis on patients' anxiety and depression after polypectomy, and provide evidence to improve post-polypectomy care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The participants, care providers, investigators and outcome assessors are not blinded to the assigned study arm.
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of ≥ 40 years and < 80 years
- •Outpatients who prepare receiving sedated colonoscopy
- •Subjects who have signed informed consent form of this study
- •Informed consensus has been obtained that endoscopic resection should be performed if a colorectal polyp is found
- •Eastern Cooperative Oncology Group (ECOG) performance status scale among 0 to 2
排除标准
- •Subjects with any of the following prior history or current conditions:
- •(a) Contraindications to colonoscopy
- •(b) Major mental illnesses, e.g. major depressive disorder, schizophrenia, generalized anxiety disorder ...
- •(c) Inflammatory bowel disease
- •(d) Hereditary or non-hereditary polyposis syndrome, hereditary non-polyposis colorectal cancer
- •(e) Uncured colorectal cancer
- •(f) Active gastrointestinal bleeding
- •(g) Pregnancy
- •Subjects who do not received polypectomy during colonoscopy.
结局指标
主要结局
Proportion of definite anxiety cases
时间窗: This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy)..
The level of anxiety of the two study arms will be measured by using the Taiwan version questionnaire of Hospital Anxiety and Depression Scale (HADS) right before the next scheduled clinic for histological results. The anxiety score of this questionnaire ranging from 0 to 21. Scored 0 to 7 defined as normal case, scored 8 to 10 defined as doubtful case, and scored 11 to 21 defined as definite case. The proportion of definite anxiety cases of the two study arms will be compared.
Proportion of definite depression cases
时间窗: This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy)..
The level of depression of the two study arms will be measured by using the Taiwan version questionnaire of Hospital Anxiety and Depression Scale (HADS) right before the next scheduled clinic for histological results. The depression score of this questionnaire ranging from 0 to 21. Scored 0 to 7 defined as normal case, scored 8 to 10 defined as doubtful case, and scored 11 to 21 defined as definite case. The proportion of definite depression cases of the two study arms will be compared.
次要结局
- Anxiety score(This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy)..)
- Depression score(This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy)..)
研究者
Chen-Ya Kuo
Attending physician
Fu Jen Catholic University