UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025886
Receipt number R000028126
Scientific Title Observational study for frequency and severity of postoperative intra-abdominal adhesion
Date of disclosure of the study information 2017/02/01
Last modified on 2020/03/03 19:53:03

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Basic information

Public title

Observational study for frequency and severity of postoperative intra-abdominal adhesion

Acronym

Observational study for frequency and severity of postoperative intra-abdominal adhesion

Scientific Title

Observational study for frequency and severity of postoperative intra-abdominal adhesion

Scientific Title:Acronym

Observational study for frequency and severity of postoperative intra-abdominal adhesion

Region

Japan


Condition

Condition

postoperative intra-abdominal adhesion

Classification by specialty

Surgery in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to clarify the frequency and severity of postoperative intra-abdominal adhesion site.

Basic objectives2

Others

Basic objectives -Others

Epidemiological research

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

the site and severity of postoperative intra-abdominal adhesion

Key secondary outcomes

the frequency of complications associated with postoperative intra-abdominal adhesion


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who fills everything the
following
(1)Patients with diverting ileostomy who are undergone stoma closure
(2)Patients who are able to provide written informed consent

Key exclusion criteria

(1)Patients who are not eligible due to physician's judgment

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Koji
Middle name
Last name Okabayashi

Organization

Keio University School of Medicine

Division name

Departement of Surgery

Zip code

160-8582

Address

Shinanomachi 35, Shinjyuku-ku, Tokyo, Japan

TEL

0353633800

Email

matsu10oka23@gmail.com


Public contact

Name of contact person

1st name Koji
Middle name
Last name Okabyashi

Organization

Keio University School of Medicine

Division name

Departement of Surgery

Zip code

160-8582

Address

Shinanomachi 35, Shinjyuku-ku, Tokyo, Japan

TEL

0353633800

Homepage URL


Email

matsu10oka23@gmail.com


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Keio University School of Medicine

Address

Shinanomachi 35, Shinjyuku-ku, Tokyo, Japan

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.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



Other administrative information

Date of disclosure of the study information

2017 Year 02 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

2016 Year 12 Month 26 Day

Date of IRB

2016 Year 11 Month 29 Day

Anticipated trial start date

2017 Year 02 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The observation of intra-abdominal adhesion by using laparoscopy when we perform stoma closure for diverting ileostomy.


Management information

Registered date

2017 Year 01 Month 27 Day

Last modified on

2020 Year 03 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028126


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name