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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047795
Receipt No. R000054489
Scientific Title Endoscopic Phenotype of the J pouch in Patients with Ulcerative Colitis: A multi-center retrospective study in Japan
Date of disclosure of the study information 2022/06/15
Last modified on 2022/05/18

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Basic information
Public title Endoscopic Phenotype of the J pouch in Patients with Ulcerative Colitis: A multi-center retrospective study in Japan
Acronym Endoscopic Phenotype of the J pouch in Patients with Ulcerative Colitis: A multi-center retrospective study in Japan
Scientific Title Endoscopic Phenotype of the J pouch in Patients with Ulcerative Colitis: A multi-center retrospective study in Japan
Scientific Title:Acronym Endoscopic Phenotype of the J pouch in Patients with Ulcerative Colitis: A multi-center retrospective study in Japan
Region
Japan

Condition
Condition Ulcerative Colitis
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This multi-center retrospective study aims to understand contributing factors to pouch outcomes (chronic pouchitis and pouch failure) by evaluating clinical data and endoscopic pouch phenotypes in patients with ulcerative colitis treated by total proctocolectomy and ileal pouch-anal anastomosis.
Basic objectives2 Others
Basic objectives -Others To clarify the relevance between endoscopic pouch phenotype and outcomes using multi-center data
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The frequency of chronic pouchitis and pouch failure
Key secondary outcomes Acute pouchitis, Endoscopic phenotype in patients with acute or chronic pouchitis, Early endoscopic phenotype in patients with chronic pouchitis, co-relationship between clinical symptoms and endoscopic phenotype, and so on

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Ulcerative colitis patients with medically refractory disease or colitis-associated cancer who required total proctocolectomy with IAA (Ileoanal anastomosis) or IACA (Ileoanal canal anastomosis) between January 2000 and March 2020. Age of the included patients is 18 or more than 18 years old.
Key exclusion criteria (1) Patients who were preoperatively diagnosed with Crohn's disease or indeterminate colitis (IBD unclassified)
(2) Patients who did not perform pouchoscopies after ileostomy takedown
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Kiichiro
Middle name
Last name Tsuchiya
Organization University of Tsukuba
Division name Department of Gastroenterology, Faculty of Medicine
Zip code 305-8575
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL 029-853-3218
Email kii.gast@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name Shintaro
Middle name
Last name Akiyama
Organization University of Tsukuba
Division name Department of Gastroenterology, Faculty of Medicine
Zip code 305-8575
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL 029-853-3218
Homepage URL
Email akiyama@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization University of tsukuba hospital
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel 029-853-3219
Email tcredo@md.tsukuba.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 国立大学法人 筑波大学 医学医療系 消化器内科 
〒305-8575 茨城県つくば市天王台1-1-1 Tel/Fax:029-853-3218

学校法人 兵庫医科大学 医学部 消化器外科学講座 炎症性腸疾患外科
〒663-8501 兵庫県西宮市武庫川町1-1 Tel/Fax:0798-45-6111

国立大学法人 佐賀大学 医学部 消化器内科
〒849-8501 佐賀県佐賀市鍋島5-1-1 Tel/Fax:0952-31-6511

横浜市立市民病院 炎症性腸疾患科
〒221-0855 神奈川県横浜市神奈川区三ツ沢西町1-1 Tel/Fax:045-316-4580

公立学校法人 奈良県立医科大学 医学部 消化器・総合外科 中央内視鏡部
〒634-8522 奈良県橿原市四条町840 Tel/Fax:0744-22-3051

学校法人 慶應義塾大学 医学部 消化器内科 内視鏡センター
〒160-8582 東京都新宿区信濃町35 Tel/Fax:03-3353-1211

医療法人社団 康喜会 辻中病院柏の葉 消化器内科
〒277-0871 千葉県柏市若柴178番地2柏の葉キャンパス148街区6 Tel/Fax:04-7137-3737

国立大学法人 東京医科歯科大学 医学部 消化器内科 
〒113-8519 東京都文京区湯島1-5-45 Tel/Fax:03-3813-6111

国立大学法人 広島大学 医学部 消化器内科 
〒734-8551 広島県広島市南区霞1-2-3 Tel/Fax:082-257-5555

国立大学法人 旭川医科大学 医学部 内科学講座 病態代謝・消化器・血液腫瘍制御内科学分野(消化器・内視鏡学部門)
〒078-8510 北海道旭川市緑が丘東2条1丁目1-1 Tel/Fax:0166-68-2462

学校法人 関西医科大学 医学部 内科学第三講座 
〒573-1191 大阪府枚方市新町2-3-1 Tel/Fax:072-804-0101

東北大学病院 医科診療部門 総合外科 
〒980-8574 宮城県仙台市青葉区星陵町1-1 Tel/Fax:022-717-7000

Other administrative information
Date of disclosure of the study information
2022 Year 06 Month 15 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
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 Preinitiation
Date of protocol fixation
2022 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date
2022 Year 07 Month 01 Day
Last follow-up date
2028 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will start collecting data at 12 institutes as a multi-center retrospective study from July 2022.

Management information
Registered date
2022 Year 05 Month 18 Day
Last modified on
2022 Year 05 Month 18 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054489

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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