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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000048092
Receipt No. R000054813
Scientific Title Safety of full bowel preparation and colonoscopy in elderly patients with ulcerative colitis: a real-world multicenter retrospective cohort study
Date of disclosure of the study information 2022/06/20
Last modified on 2022/06/17

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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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