UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047154 |
|---|---|
| Receipt number | R000053765 |
| Scientific Title | The efficacy of Subcutaneous Incision of the Fistula Tract and Internal Sphincterotomy(SIFT-IS) for transsphincteric anal fistulas |
| Date of disclosure of the study information | 2022/03/15 |
| Last modified on | 2022/03/10 21:41:14 |
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Basic information
Public title
The efficacy of Subcutaneous Incision of the Fistula Tract and Internal Sphincterotomy(SIFT-IS) for transsphincteric anal fistulas
Acronym
The efficacy of SIFT-IS for anal fistulas
Scientific Title
The efficacy of Subcutaneous Incision of the Fistula Tract and Internal Sphincterotomy(SIFT-IS) for transsphincteric anal fistulas
Scientific Title:Acronym
The efficacy of SIFT-IS for anal fistulas
Region
| Japan |
Condition
Condition
Transsphincteric anal fistula
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of SIFT-IS in patients with transsphincteric anal fistulas
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative healing rate at 16 weeks
Key secondary outcomes
Healing time,postoperative complications,and clinical continence status
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
Performing SIFT-IS for transsphincteric anal fistula
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Transsphincteric anal fistula
Key exclusion criteria
Complicated fistulas(multiple fistulas,recurrent fistula,and horseshoe fistula)
IBD associated fistulas
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Rikisaburo |
| Middle name | |
| Last name | Sahara |
Organization
Makita General Hospital
Division name
Division of Coloproctology
Zip code
143-8505
Address
4-22-1 Nishikamata,Ohta-ku,Tokyo 143-8505,Japan
TEL
03(5748)5020
riki58sahara@gmail.com
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Morimoto |
Organization
Nishiarai Coloproctology Clinic
Division name
Division of Coloproctology
Zip code
121-0815
Address
3-7-13 Shimane,Adachi-ku,Tokyo 121-0815 Japan
TEL
03(3883)2020
Homepage URL
morimo69@gmail.com
Sponsor or person
Institute
JCHO Tokyo Yamate Mrdical Center
Institute
Department
Personal name
Funding Source
Organization
Nishiarai Coloproctology Clinic
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
JCHO Tokyo Yamate Medical Center
Address
3-22-1 Hyakunin-cho,Shinjuku-ku,Tokyo 169-0073,Japan
Tel
03(3364)0251
morimo69@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 | 03 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | 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 | 03 | Month | 11 | Day |
Last modified on
| 2022 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053765
