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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027622
Receipt No. R000031649
Scientific Title Pouch functional outcomes after restorative proctocolectomy with ileal-pouch reconstruction in patients with ulcerative colitis: Japanese multi-center nationwide cohort study
Date of disclosure of the study information 2017/06/03
Last modified on 2017/06/03

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Basic information
Public title Pouch functional outcomes after restorative proctocolectomy with ileal-pouch reconstruction in patients with ulcerative colitis: Japanese multi-center nationwide cohort study
Acronym Pouch outcome after surgery for UC
Scientific Title Pouch functional outcomes after restorative proctocolectomy with ileal-pouch reconstruction in patients with ulcerative colitis: Japanese multi-center nationwide cohort study
Scientific Title:Acronym Pouch outcome after surgery for UC
Region
Japan

Condition
Condition ulcerative colitis
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Although several complications capable of causing pouch failure may develop after restorative proctocolectomy for ulcerative colitis, the incidences and causes are conflicting and vary according to country, race, and institution. To avoid pouch failure, this study aimed to evaluate the rate of pouch failure and its risk factors in UC patients over the past decade via a nationwide cohort study.
Basic objectives2 Others
Basic objectives -Others To evaluated the asssociation between post-operative complication and pouch function
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes ithe incidence of pouch failure
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were treated with restorative proctocolectomy
Key exclusion criteria Patients without restorative proctocolectomy
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoi Uchino
Organization Hyogo college of medicine
Division name department of Inflammatory Bowel disease
Zip code
Address 1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6371
Email uchino2s@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoi Uchino
Organization Hyogo College of Medicine
Division name Department of Inflammatory Bowel Disease
Zip code
Address 1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6371
Homepage URL
Email uchino2s@hyo-med.ac.jp

Sponsor
Institute Hyogo college of medicine
Institute
Department

Funding Source
Organization a research grant on intractable disease affiliated with the Japan Ministry of Health, Labor 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
Address
Tel
Email

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
2017 Year 06 Month 03 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
The significant risk factor for a non-functional pouch was anastomotic leakage. The optimal staged surgical procedure should be selected according to a patient's condition to avoid anastomotic failure during RPC. Changes in diagnosis after RPC confer a substantial risk of pouch failure
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 Completed
Date of protocol fixation
2015 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 20 Day
Last follow-up date
2017 Year 01 Month 31 Day
Date of closure to data entry
2017 Year 01 Month 31 Day
Date trial data considered complete
2017 Year 01 Month 31 Day
Date analysis concluded
2017 Year 01 Month 31 Day

Other
Other related information A total of 2,376 patients were evaluated over 8.2years of follow-up. Twenty-seven non-functional pouches were observed, and the functional pouch rate was 98.9% after RPC. Anastomotic leakage (odds ratio, 9.1) was selected as a risk factor for a non-functional pouch. The cumulative pouch failure was 4.2%/10 years. A change in diagnosis to Crohn's disease/indeterminate colitis (hazard ratio 13.2) was identified as an independent risk factor for pouch failure.

Management information
Registered date
2017 Year 06 Month 03 Day
Last modified on
2017 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031649

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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