UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048092 |
|---|---|
| Receipt number | 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 16:42:38 |
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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
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
y_hashi@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054813
