UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000027622
Receipt number	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 11:05:17

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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

ulcerative colitis

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

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 or person

Institute

Hyogo college of medicine

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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