Impact of Real-time Notification of Colonoscopic Optical Diagnosis on Patients' Anxiety and Depression After Polypectomy
NCT ID: NCT05517343
Last Updated: 2022-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2022-08-20
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ordinary care (OC)
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).
No interventions assigned to this group
Real-time notification (RTN)
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* (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.
40 Years
79 Years
ALL
No
Sponsors
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Fu Jen Catholic University
OTHER
Responsible Party
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Chen-Ya Kuo
Attending physician
Locations
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Fu Jen Catholic University Hospital
New Taipei City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
Other Identifiers
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FJUH111207
Identifier Type: -
Identifier Source: org_study_id
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