To hear about similar clinical trials, please enter your email below
Trial Title:
Impact of Real-time Notification of Colonoscopic Optical Diagnosis on Patients' Anxiety and Depression After Polypectomy
NCT ID:
NCT05517343
Condition:
Colorectal Neoplasms
Colonic Polyp
Anxiety
Depression
Colonoscopy
Conditions: Official terms:
Colorectal Neoplasms
Colonic Polyps
Depression
Depressive Disorder
Anxiety Disorders
Conditions: Keywords:
colonoscopy
polypectomy
image enhanced endoscopy
endoscopic optical diagnosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Masking description:
The participants, care providers, investigators and outcome assessors are not blinded to
the assigned study arm.
Intervention:
Intervention type:
Other
Intervention name:
Real-time endoscopic optical diagnosis
Description:
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.
Arm group label:
Real-time notification (RTN)
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.
Criteria for 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.
Gender:
All
Minimum age:
40 Years
Maximum age:
79 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fu Jen Catholic University Hospital
Address:
City:
New Taipei City
Zip:
24352
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chen-Ya Kuo, MD
Phone:
886975701515
Email:
b9402039@gmail.com
Start date:
August 20, 2022
Completion date:
August 31, 2025
Lead sponsor:
Agency:
Fu Jen Catholic University
Agency class:
Other
Source:
Fu Jen Catholic University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05517343
