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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015754
Receipt No. R000017706
Scientific Title Postoperative stricture after endoscopic submucosal dissection for large colorectal tumors
Date of disclosure of the study information 2015/05/12
Last modified on 2016/12/03

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Basic information
Public title Postoperative stricture after endoscopic submucosal dissection for large colorectal tumors
Acronym Postoperative stricture after endoscopic submucosal dissection for large colorectal tumors
Scientific Title Postoperative stricture after endoscopic submucosal dissection for large colorectal tumors
Scientific Title:Acronym Postoperative stricture after endoscopic submucosal dissection for large colorectal tumors
Region
Japan

Condition
Condition Mucosal and submucosal colorectal neoplasm
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the risk factor of posoperative stricture after endoscopic submucosal dissection in the colorectum
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Postoperative stricure was diagnosed when a standard 11.5mm diameter colonoscope could not be negotiated through the colonic segment at the site of ESD.
Follow-up endoscopy was performed 4 to 6 months later. If patients had any different clinical symptoms from those prior to the ESD, endoscopy was performed in order to check for post-ESD stenosis.
All cases were divided into two groups, that is, presence or absence of postoperative stricture. The two groups were compared in respect of the patient age, gender, concomitant disease that might affect ESD ulcer healing, the tumor location, macroscopic type, longitudinal and circumferential diameter of the resected specimens, circumferential extent of the mucosal defect, and depth of invasion.The risk factor of postoperative stricure is clarified
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All cases that colorectal neoplasm is resected by endoscopic submucosal dissection
Key exclusion criteria The case that colorectal neoplasm can not be resected by endoscopic submucosal dissection
Target sample size 700

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TAKEMASA HAYASHI
Organization Showa University Northern Yokohama Hospital
Division name Digective Disease Center
Zip code
Address 35-1 Chigasaki-chuo Tsuzuki Yokohama Kanagawa
TEL 045-949-7717
Email take09043946487@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name TAKEMASA HAYASHI
Organization Showa University Northern Yokohama Hospital
Division name Digective Disease Center
Zip code
Address 35-1 Chigasaki-chuo Tsuzuki Yokohama Kanagawa
TEL 045-949-7717
Homepage URL
Email take09043946487@yahoo.co.jp

Sponsor
Institute Showa University Northern Yokohama Hospital, Digestive Disease center
Institute
Department

Funding Source
Organization non
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
2015 Year 05 Month 12 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
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2015 Year 05 Month 31 Day
Date analysis concluded

Other
Other related information case control study
retrospective study

Management information
Registered date
2014 Year 11 Month 26 Day
Last modified on
2016 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017706

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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