UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009443 |
|---|---|
| Receipt number | R000010806 |
| Scientific Title | Evaluation of intestinal stenosis by Patency Capsule in patients with intestinal obstruction after recovery |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2015/06/08 14:34:37 |
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Basic information
Public title
Evaluation of intestinal stenosis by Patency Capsule in patients with intestinal obstruction after recovery
Acronym
Evaluation of intestinal stenosis by Patency Capsule for patients with intestinal obstruction after recovery
Scientific Title
Evaluation of intestinal stenosis by Patency Capsule in patients with intestinal obstruction after recovery
Scientific Title:Acronym
Evaluation of intestinal stenosis by Patency Capsule for patients with intestinal obstruction after recovery
Region
| Japan |
Condition
Condition
Intestinal obstruction
Classification by specialty
| Medicine in general | Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the degree of stenosis in patients with intestinal obstruction after recovery by using Patency Capsule, to consider dietary intervention and subsequent recurrence of bowel obstruction
Basic objectives2
Others
Basic objectives -Others
Recurrence of intestinal obstruction after the start of feeding
Validity of the results of Patency capsule by intestinal stenosis when surgical treatment was required
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of patency (excretory rate, deformation ratio, emptying time)
Key secondary outcomes
Recurrence of recurrent intestinal obstruction after the start of the meal
Validity of the results of Patency capsule by intestinal stenosis when surgical treatment was required
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Enforcement of a patency capsule
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
Intestinal obstruction has been improved. (passage of stool and flatus were observed).
Passage of the contrast agent can be confirmed by angiography
Able to provide informed consent
Key exclusion criteria
1.Patient with strangulating intestinal obstruction.
2.Patient with complete intestinal obstruction based on contrast study.
3.Patient with colon obstruction
4.Patient with dysphasia
5.Patient with allergy to barium.
6.Patient suspected to have complete intestinal obstruction
7.Patient under 20 years old
8.Serious infectious disease
9.Use or history of peritoneal dialysis
10.Patient who was judged unsuitable by the attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyoshi Shibuya |
Organization
Department of Internal Medicine, Juntendo University
Division name
Gastroenterology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
tomoyosi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyoshi Shibuya |
Organization
Department of Internal Medicine, Juntendo University
Division name
Gastroenterology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
tomoyosi@juntendo.ac.jp
Sponsor or person
Institute
Department of Internal Medicine, Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine,Juntendo 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
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
| 2012 | Year | 12 | Month | 01 | 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
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 30 | Day |
Last modified on
| 2015 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010806
