Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.