UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049233 |
|---|---|
| Receipt number | R000056074 |
| Scientific Title | Colonoscopy -assisted percutaneous sigmoidopexy for the treatment of complete rectal prolapse |
| Date of disclosure of the study information | 2022/10/17 |
| Last modified on | 2022/10/17 02:15:02 |
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Basic information
Public title
Colonoscopy -assisted percutaneous sigmoidopexy for the treatment of complete rectal prolapse
Acronym
CAPS for the treatment of complete rectal prolapse
Scientific Title
Colonoscopy -assisted percutaneous sigmoidopexy for the treatment of complete rectal prolapse
Scientific Title:Acronym
CAPS for the treatment of complete rectal prolapse
Region
| Japan |
Condition
Condition
complete rectal prolapse
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy and safety of colonoscopy -assisted percutaneous sigmoidopexy for the treatment of complete rectal prolapse
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
operative time
Key secondary outcomes
blood loss, complications, recurrence rate, and symptom improvement
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Colonoscopy-assisted percutaneous sigmoidopexy
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
consecutive participants diagnosed with complete rectal prolapse at the outpatient department of the International University of Health and Welfare Hospital.
Key exclusion criteria
Patients who do not undergo the treatment procedure after receiving an explanation of the details of the study are not included.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Takahashi |
Organization
International University of Health and Welfare Hospital
Division name
Department of surgery
Zip code
3292763
Address
537-3, Iguchi, Nasushiobara City, Tochigi
TEL
+81287372221
jtakahashi1127@gmail.com
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Takahashi |
Organization
International University of Health and Welfare Hospital
Division name
Department of surgery
Zip code
3292763
Address
537-3, Iguchi, Nasushiobara City, Tochigi
TEL
+81287372221
Homepage URL
jtakahashi1127@gmail.com
Sponsor or person
Institute
International University of Health and Welfare Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
International University of Health and Welfare Hospital
Address
537-3, Iguchi, Nasushiobara City, Tochigi
Tel
+81287372221
jtakahashi1127@gmail.com
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
| 2022 | Year | 10 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2036 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 17 | Day |
Last modified on
| 2022 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056074
