Clinical trial NCT05517343: Impact of Real-time Notification of Colonoscopic Optical Diagnosis on Patients' Anxiety and Depression After Polypectomy
Official title: Impact of Real-time Notification of Colonoscopic Optical Diagnosis on Patients' Anxiety and Depression After Polypectomy: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Neoplasms
Colonic Polyp
Anxiety
Depression
Colonoscopy
Keywords: colonoscopy
polypectomy
image enhanced endoscopy
endoscopic optical diagnosis
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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 and received polypectomy during the procedure. Participants will be randomized into "ordinary care group (explained at next scheduled clinic)" and "real-time notification group (explained immediately after colonoscopy)" in 1:1 ratio. Randomization will be based on a computer-generalized randomization list and stratified by gender and baseline anxiety degree of the participants. The level of anxiety, depression of the two groups will be measured by using the Taiwan version questionnaire of Hospital Anxiety and Depression Scale right before the next scheduled clinic for histological results and compared the difference between the two groups.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of definite anxiety cases
timeFrame: This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy)..
measure: Proportion of definite depression cases
timeFrame: This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy)..
Secondary outcomes:
measure: Anxiety score
timeFrame: This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy)..
measure: Depression score
timeFrame: This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy)..
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital
Study officials:
References:
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