UMIN-CTR Clinical Trial

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
Email	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
Email	morimo69@gmail.com

Sponsor
Institute	JCHO Tokyo Yamate Mrdical Center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053765