Impact of Real-time Notification of Colonoscopic Optical Diagnosis on Patients' Anxiety and Depression After Polypectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Real-time Notification of Colonoscopic Optical Diagnosis on Patients' Anxiety and Depression After Polypectomy: a Randomized Control Trial

Conditions
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Colorectal Neoplasms, Colonic Polyp, Anxiety, Depression, Colonoscopy

Intervention / Treatment
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* Other: Real-time endoscopic optical diagnosis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Ordinary care (OC)<br>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). | |
| Experimental: Real-time notification (RTN)<br>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). | Other: Real-time endoscopic optical diagnosis<br>* The participants assigned to real-time notification group will received the endoscopic diagnosis of the resected colorectal polyps and recommended surveillance colonoscopy schedule right after the sedated colonoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of definite anxiety cases | 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. | This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy).. | 
| Proportion of definite depression cases | 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. | This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy).. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety score | 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 and compared the difference between the two study arms. The anxiety score of this questionnaire ranging from 0 to 21. Higher score means higher anxiety level. | This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy).. | 
| Depression score | 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 and compared the difference between the two study arms. The depression score of this questionnaire ranging from 0 to 21. Higher score means higher depression level. | This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy).. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, polypectomy, image enhanced endoscopy, endoscopic optical diagnosis