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

Fu Jen Catholic University

Status: Enrolling

Conditions: Colonic Polyp; Colonoscopy; Depression; Colorectal Neoplasms; Anxiety

Treatments: Other: Real-time endoscopic optical diagnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05517343

FJUH111207

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 40 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Ordinary care (OC)

No Intervention group

Description:

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)

Experimental group

Description:

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).

Treatment:

Other: Real-time endoscopic optical diagnosis