UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032356
Receipt number R000035699
Scientific Title The efficacy of prophylactic catheter insertion for outlet obstruction in patients with ulcerative colitis after surgery.
Date of disclosure of the study information 2018/05/01
Last modified on 2018/08/24 09:59:39

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Basic information

Public title

The efficacy of prophylactic catheter insertion for outlet obstruction in patients with ulcerative colitis after surgery.

Acronym

The efficacy of prophylactic catheter insertion for outlet obstruction in patients with ulcerative colitis after surgery.

Scientific Title

The efficacy of prophylactic catheter insertion for outlet obstruction in patients with ulcerative colitis after surgery.

Scientific Title:Acronym

The efficacy of prophylactic catheter insertion for outlet obstruction in patients with ulcerative colitis after surgery.

Region

Japan


Condition

Condition

Ulcerative colitis

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the efficacy of inserting prophylactic catheter from ileostomy for outlet obstruction in patients with ulcerative colitis after surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I


Assessment

Primary outcomes

incidence of the outlet obstruction during hospitalization

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Inserting catheter from loop ileostomy
Natural extraction or 1 week

Interventions/Control_2

Without inserting catheter from loop ileostomy

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

Patients with loop ileostomy.
Patients with agreement.

Key exclusion criteria

Patients without agreement.

Target sample size

320


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Teruhiro Chohno

Organization

Hyogo College of Medicine

Division name

Department of Inflammatory Bowel Disease

Zip code


Address

1-1 Mukogawacho, Nishinomiya, Hyogo, Japan

TEL

0798456371

Email

chohnoo@hyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Teruhiro Chohno

Organization

Hyogo College of Medicine

Division name

Department of Inflammatory Bowel Disease

Zip code


Address

1-1 Mukogawacho, Nishinomiya, Hyogo, Japan

TEL

0798456371

Homepage URL


Email

chohnoo@hyo-med.ac.jp


Sponsor or person

Institute

Department of Inflammatory Bowel Disease
Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Inflammatory Bowel Disease
Hyogo College of Medicine

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


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

2018 Year 05 Month 01 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

Open public recruiting

Date of protocol fixation

2018 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 04 Month 24 Day

Last modified on

2018 Year 08 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035699


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name