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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016559
Receipt No. R000019214
Scientific Title Stricture after circumferential and sub-circumferential endoscopic submucosal dissection for large rectal neoplasms
Date of disclosure of the study information 2015/02/20
Last modified on 2015/02/17

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Basic information
Public title Stricture after circumferential and sub-circumferential endoscopic submucosal dissection for large rectal neoplasms
Acronym Stricture after circumferential and sub-circumferential endoscopic submucosal dissection for large rectal neoplasms
Scientific Title Stricture after circumferential and sub-circumferential endoscopic submucosal dissection for large rectal neoplasms
Scientific Title:Acronym Stricture after circumferential and sub-circumferential endoscopic submucosal dissection for large rectal neoplasms
Region
Japan

Condition
Condition Tumors in rectum
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine strictures of the rectum after ESD
Basic objectives2 Others
Basic objectives -Others To determine the risk factors for developing strictures of the rectum after ESD and effective therapies for it
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Stricture rate after ESD for large lesions in rectum
Key secondary outcomes The risk factors for developing strictures of the rectum after ESD and effective therapies for it

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
90 years-old >=
Gender Male and Female
Key inclusion criteria The patients who underwent ESD for the rectal tumors and whose treatments resulted in more than 3/4 circumferential resection at Kobe University Hospital and Kishiwada Tokushukai Hospital between April 2005 and May 2014
Key exclusion criteria The patients who refused to be involved in this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Toyonaga
Organization Kobe University Hospital
Division name Department of Endoscopy
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-5774
Email toyonaga@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Toyonaga
Organization Kobe University Hospital
Division name Department of Endoscopy
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-5774
Homepage URL
Email toyonaga@med.kobe-u.ac.jp

Sponsor
Institute Division of Gastroenterology, Department of Internal Medicine, Graduate School of Medicine, Kobe University
Institute
Department

Funding Source
Organization Division of Gastroenterology, Department of Internal Medicine, Graduate School of Medicine, Kobe University
Organization
Division
Category of Funding Organization Other
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
2015 Year 02 Month 20 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 Completed
Date of protocol fixation
2014 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We collected the data about patients who required more than 75% circumferential resection at Kobe University Hospital and Kishiwada Tokushukai Hospital between April 2005 and May 2014, and were evaluated for strictures by follow-up colonoscopy and/or using additional surgical specimens. Then, we investigated the probabilities of post-ESD stricture, risk factors, and the effective stricture treatments.

Management information
Registered date
2015 Year 02 Month 17 Day
Last modified on
2015 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019214

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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