UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015754 |
|---|---|
| Receipt number | 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 12:48:17 |
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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
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
take09043946487@yahoo.co.jp
Sponsor or person
Institute
Showa University Northern Yokohama Hospital, Digestive Disease center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017706
