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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | ulcerative colitis | |
Classification by specialty |
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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 | |
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Blocking | |
Concealment |
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Eligibility | ||||
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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 |
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Name of lead principal investigator |
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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 |
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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 | |
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 |
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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 | |
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Date of disclosure of the study information |
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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 | |
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Baseline Characteristics | |
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Recruitment status | No longer recruiting | ||||||
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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. |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054813 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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