UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012771 |
|---|---|
| Receipt number | R000012601 |
| Scientific Title | Endoscopic Radial Incision and Cutting (RIC) Method for Rectal Postoperative Stricture. |
| Date of disclosure of the study information | 2014/01/07 |
| Last modified on | 2020/01/30 01:00:11 |
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Basic information
Public title
Endoscopic Radial Incision and Cutting (RIC) Method for Rectal Postoperative Stricture.
Acronym
Rectal RIC
Scientific Title
Endoscopic Radial Incision and Cutting (RIC) Method for Rectal Postoperative Stricture.
Scientific Title:Acronym
Rectal RIC
Region
| Japan |
Condition
Condition
Rectal postoperative stricture
Classification by specialty
| Medicine in general | Gastroenterology | Surgery in general |
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess usefulness of endoscopic RIC for rectal postoperative stricture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
We will assess whether rectal RIC brings adequate and effective expansion at the stricture site which is large enough to allow endoscope to pass.
Key secondary outcomes
1.patency period
2.rate of adverse event
3.procedure time
4.cost (hospitalization cost)
5.degree of the patient's pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic RIC
Interventions/Control_2
regular surgery
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
1. past histry of rectal surgery
2. anastomotic stricture occurs obstruction
Key exclusion criteria
1. having risk for RIC
2. no hope of QOL improvement by any treatment
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Harada |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology
Zip code
700-8558
Address
2-5-1 Shikata-cho Kita-ku Okayama, Japan
TEL
+81-86-235-7219
keita818@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Harada |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology
Zip code
700-8558
Address
2-5-1 Shikata-cho Kita-ku Okayama, Japan
TEL
+81-86-235-7219
Homepage URL
keita818@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
Department of Gastroenterology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
Tel
+81-86-235-7219
keita818@cc.okayama-u.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
| 2014 | Year | 01 | Month | 07 | 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
| 2013 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 07 | Day |
Last modified on
| 2020 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012601
