Impact of Real-time Notification of Colonoscopic Optical Diagnosis on Patients' Anxiety and Depression After Polypectomy: a Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Fu Jen Catholic University
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Proportion of definite anxiety cases
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
The participants, care providers, investigators and outcome assessors are not blinded to the assigned study arm.
Eligibility Criteria
- Ages
- 40 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Ordinary care (OC)
The participants of this arm received the endoscopic optical diagnosis, histological diagnosis of the resected colon polyps and the recommended surveillance colonoscopy schedule at next scheduled clinic visit (around 1 to 2 weeks later).
Real-time notification (RTN)
The participants of this arm received the endoscopic optical diagnosis of the resected colon polyps and the recommended surveillance colonoscopy schedule right after the sedated colonoscopy. Histological diagnosis will be informed at next scheduled clinic visit (around 1 to 2 weeks later).
Intervention: Real-time endoscopic optical diagnosis (Other)
Outcomes
Primary Outcomes
Proportion of definite anxiety cases
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)..)
Investigators
Chen-Ya Kuo
Attending physician
Fu Jen Catholic University