UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical outcomes after insertion of transanal decompression tube for obstructive colorectal cancer in common clinical practice
Title of the study (Brief title)	colorectal drainage study
Region	Japan

Condition
Condition	Obstructive colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Efficacy of transanal decompression tube for obstructive colorectal cancer in common clinical practice
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	rate of primary stoma post oparative complication
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 of obstrucitive colorectal cancer for the past 5 years in each hospital
Key exclusion criteria	none
Target sample size	200

Research contact person
Name of lead principal investigator	Takuji Kawamura
Organization	Kyoto Second Red Cross Hospital
Division name	Gastroenterology
Address	355-5, Haruobi-cho, Kamigyo-ku, Kyoto, Japan
TEL	075-231-5171
Email	kawamurat@kyoto2.jrc.or.jp

Public contact
Name of contact person	Takuji Kawamura
Organization	Kyoto Second Red Cross Hospital
Division name	Gastroenterology
Address	355-5, Haruobi-cho, Kamigyo-ku, Kyoto, Japan
TEL	075-231-5171
Homepage URL
Email	kawamurat@kyoto2.jrc.or.jp

Sponsor
Institute	Kwansai Endoscopic Device Selection Study Group
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 03 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 12 Day
Anticipated trial start date	2014 Year 03 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Multicencer retrospective analysis of transanal drainage tube for obstructive colorectal cancer

Management information
Registered date	2014 Year 03 Month 03 Day
Last modified on	2016 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015544