UMIN-CTR Clinical Trial

Basic information
Public title	Safety of full bowel preparation and colonoscopy in elderly patients with ulcerative colitis: a real-world multicenter retrospective cohort study
Acronym	Safety of colonoscopy in elderly patients with ulcerative colitis
Scientific Title	Safety of full bowel preparation and colonoscopy in elderly patients with ulcerative colitis: a real-world multicenter retrospective cohort study
Scientific Title:Acronym	Safety of colonoscopy in elderly patients with ulcerative colitis
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to determine the safety of full bowel preparation and colonoscopy in elderly patients with UC.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The safety endpoints were as follows: incidence, severity, and outcomes of complications of colonoscopy, such as bleeding, perforation, and laceration; complications associated with bowel preparation, such as vomiting and intestinal obstruction; and the rate of relapse of UC after colonoscopy.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	This retrospective study included a cohort of patients with IBD who visited any of 12 hospitals in the Gunma Prefecture in Japan and are registered in our IBD database as of December 2021
Key exclusion criteria	The following exclusion criteria were applied: previous colonic resection; follow-up duration of less than 6 months; suspected cytomegalovirus infection in the colon or other type of infectious colitis; multiple colonoscopies during the study period; incomplete colonoscopy because of poor bowel preparation; and patient's request for discontinuation.
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Toshio Middle name Last name Uraoka
Organization	Gunma University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	3718511
Address	3-39-15 Showa-machi, Maebashi, Gunma
TEL	0272208137
Email	y_hashi@gunma-u.ac.jp

Public contact
Name of contact person	1st name Yu Middle name Last name Hashimoto
Organization	Gunma University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	3718511
Address	3-39-15 Showa-machi, Maebashi, Gunma
TEL	0272208137
Homepage URL
Email	y_hashi@gunma-u.ac.jp

Sponsor
Institute	Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address	3-39-15 Showa-machi Maebashi, Gunma
Tel	0272208137
Email	hitotaisho-ciru@ml.gunma-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	249
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2021 Year 11 Month 11 Day
Date of IRB	2021 Year 11 Month 11 Day
Anticipated trial start date	2021 Year 11 Month 16 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The safety endpoints were as follows: incidence, severity, and outcomes of complications of colonoscopy, such as bleeding, perforation, and laceration; complications associated with bowel preparation, such as vomiting and intestinal obstruction; and the rate of relapse of UC after colonoscopy. We often encounter patients with UC who complain of worsening symptoms after colonoscopy; whether these complaints reflect the burden of bowel preparation or the colonoscopy procedure itself is unclear14,15). We assessed the endoscopic severity, clinical severity, biopsy findings, and bowel preparation method used in patients who developed endoscopic complications or had a relapse of UC after colonoscopy. Finally, we investigated the characteristics and prognosis of patients who were unable to undergo colonoscopy or were deemed unfit for the procedure by the attending physician because of a past history or condition from which recovery was not expected.

Management information
Registered date	2022 Year 06 Month 17 Day
Last modified on	2022 Year 06 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054813

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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