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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2025
  • participants needed
    500
  • sponsor
    Fu Jen Catholic University
Updated on 7 October 2022
anxiety
polypectomy
colonoscopy
colorectal polyps
depressed mood
endoscopic resection

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.

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.

Details
Condition Colorectal Neoplasms, Colonic Polyp, Anxiety, Depression, Colonoscopy
Treatment Real-time endoscopic optical diagnosis
Clinical Study IdentifierNCT05517343
SponsorFu Jen Catholic University
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note