UnknownNot Applicable

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

Taiwan500 participantsStarted 2022-08-20

Plain-language 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.

Who can participate

Age range

40 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)..

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)..

Trial details

NCT IDNCT05517343

SponsorFu Jen Catholic University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-31

Contact for this trial

Chen-Ya Kuo, bachelor

+886975701515 b9402039@gmail.com

View on ClinicalTrials.gov More Colorectal Neoplasms trials

Plain-language summary

Who can participate

Age range

40 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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)..

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)..