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

NCT05517343 | Unknown

• 1 other identifier: FJUH111207
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Neoplasms; Colonic Polyp; Anxiety; Depression; Colonoscopy

Keywords

colonoscopy; polypectomy; image enhanced endoscopy; endoscopic optical diagnosis

Outcome Measures

Primary Outcomes (2)

• 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)..

• 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 Outcomes (2)

• Anxiety score

  This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy)..

• Depression score

  This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy)..

Study Arms (2)

Ordinary care (OC)

NO INTERVENTION

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

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).

Other: Real-time endoscopic optical diagnosis

Interventions

Real-time endoscopic optical diagnosis OTHER

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.

Real-time notification (RTN)

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fu Jen Catholic University: lead

Study Sites (1)

Fu Jen Catholic University Hospital

New Taipei City, 24352, Taiwan

RECRUITING

Related Publications (11)

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  PMID: 25995082 BACKGROUND

• 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.

  PMID: 23483433 BACKGROUND

• 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.

  PMID: 23729229 BACKGROUND

• 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.

  PMID: 21266811 BACKGROUND

• 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.

  PMID: 28257790 BACKGROUND

• 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.

  PMID: 18853968 BACKGROUND

• 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.

  PMID: 30848728 BACKGROUND

• 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.

  PMID: 27644737 BACKGROUND

• 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.

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  PMID: 6880820 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Chen-Ya Kuo, bachelor

CONTACT

+886975701515; b9402039@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The participants, care providers, investigators and outcome assessors are not blinded to the assigned study arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 26, 2022
• Study Start: August 20, 2022
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)