UMIN-CTR Clinical Trial

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
Institute	Keio University School of Medicine
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028126