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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05517343
• Other study ID #: FJUH111207
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: August 2022
• Source: Fu Jen Catholic University
• Contact: Chen-Ya Kuo, bachelor
• Phone: +886975701515
• Email: b9402039[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Colonic Polyp
• Colonic Polyps
• Colonoscopy
• Colorectal Neoplasms
• Depression
• Depressive Disorder

Intervention

Other:
• Real-time endoscopic optical diagnosis
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.

Locations

Country	Name	City	State
Taiwan	Fu Jen Catholic University Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Fu Jen Catholic University

Country where clinical trial is conducted

Taiwan, 

References & Publications (11)

ASGE Technology Committee, Abu Dayyeh BK, Thosani N, Konda V, Wallace MB, Rex DK, Chauhan SS, Hwang JH, Komanduri S, Manfredi M, Maple JT, Murad FM, Siddiqui UD, Banerjee S. ASGE Technology Committee systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2015 Mar;81(3):502.e1-502.e16. doi: 10.1016/j.gie.2014.12.022. Epub 2015 Jan 16. Review. — View Citation

Backes Y, Moss A, Reitsma JB, Siersema PD, Moons LM. Narrow Band Imaging, Magnifying Chromoendoscopy, and Gross Morphological Features for the Optical Diagnosis of T1 Colorectal Cancer and Deep Submucosal Invasion: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2017 Jan;112(1):54-64. doi: 10.1038/ajg.2016.403. Epub 2016 Sep 20. Review. — View Citation

Chiu HM, Chen SL, Yen AM, Chiu SY, Fann JC, Lee YC, Pan SL, Wu MS, Liao CS, Chen HH, Koong SL, Chiou ST. Effectiveness of fecal immunochemical testing in reducing colorectal cancer mortality from the One Million Taiwanese Screening Program. Cancer. 2015 Sep 15;121(18):3221-9. doi: 10.1002/cncr.29462. Epub 2015 May 20. — View Citation

Denters MJ, Deutekom M, Bossuyt PM, Fockens P, Dekker E. Patient burden of colonoscopy after positive fecal immunochemical testing for colorectal cancer screening. Endoscopy. 2013;45(5):342-9. doi: 10.1055/s-0032-1326238. Epub 2013 Mar 12. — View Citation

Denters MJ, Deutekom M, Essink-Bot ML, Bossuyt PM, Fockens P, Dekker E. FIT false-positives in colorectal cancer screening experience psychological distress up to 6 weeks after colonoscopy. Support Care Cancer. 2013 Oct;21(10):2809-15. doi: 10.1007/s00520-013-1867-7. Epub 2013 Jun 1. — View Citation

Giorgi Rossi P, Vicentini M, Sacchettini C, Di Felice E, Caroli S, Ferrari F, Mangone L, Pezzarossi A, Roncaglia F, Campari C, Sassatelli R, Sacchero R, Sereni G, Paterlini L, Zappa M. Impact of Screening Program on Incidence of Colorectal Cancer: A Cohort Study in Italy. Am J Gastroenterol. 2015 Sep;110(9):1359-66. doi: 10.1038/ajg.2015.240. Epub 2015 Aug 25. — View Citation

Mason SE, Poynter L, Takats Z, Darzi A, Kinross JM. Optical Technologies for Endoscopic Real-Time Histologic Assessment of Colorectal Polyps: A Meta-Analysis. Am J Gastroenterol. 2019 Aug;114(8):1219-1230. doi: 10.14309/ajg.0000000000000156. Review. — View Citation

Matsuda T, Fujii T, Saito Y, Nakajima T, Uraoka T, Kobayashi N, Ikehara H, Ikematsu H, Fu KI, Emura F, Ono A, Sano Y, Shimoda T, Fujimori T. Efficacy of the invasive/non-invasive pattern by magnifying chromoendoscopy to estimate the depth of invasion of early colorectal neoplasms. Am J Gastroenterol. 2008 Nov;103(11):2700-6. doi: 10.1111/j.1572-0241.2008.02190.x. Epub 2008 Oct 3. — View Citation

Oba S, Tanaka S, Sano Y, Oka S, Chayama K. Current status of narrow-band imaging magnifying colonoscopy for colorectal neoplasia in Japan. Digestion. 2011;83(3):167-72. doi: 10.1159/000321807. Epub 2011 Jan 21. Review. — View Citation

Sumimoto K, Tanaka S, Shigita K, Hayashi N, Hirano D, Tamaru Y, Ninomiya Y, Oka S, Arihiro K, Shimamoto F, Yoshihara M, Chayama K. Diagnostic performance of Japan NBI Expert Team classification for differentiation among noninvasive, superficially invasive, and deeply invasive colorectal neoplasia. Gastrointest Endosc. 2017 Oct;86(4):700-709. doi: 10.1016/j.gie.2017.02.018. Epub 2017 Feb 28. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)..
Primary	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	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)..
Secondary	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)..