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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012530
Receipt No. R000014664
Scientific Title Anal sphincter reconstruction using a free gracilis muscle flap with nerve anastomosis
Date of disclosure of the study information 2014/01/04
Last modified on 2013/12/09

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Basic information
Public title Anal sphincter reconstruction using a free gracilis muscle flap with nerve anastomosis
Acronym Reconstruction of dynamis anal sphincter function
Scientific Title Anal sphincter reconstruction using a free gracilis muscle flap with nerve anastomosis
Scientific Title:Acronym Reconstruction of dynamis anal sphincter function
Region
Japan

Condition
Condition Anal cancer
Classification by specialty
Gastrointestinal surgery Plastic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Reconstruction of anal sphincter function after the cancer surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes anorectomanometry
Key secondary outcomes

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 From 7th/May/2012 to 31st/3/2015
We will perform the gracilis muscle transfer and nerve anastomosis for the patient after anal cancer operation
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 Patients who supporsed to lose anal phincter function after lumpectomy for anal cancer
Key exclusion criteria patients who announce their refusal to join
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Ueda
Organization Osaka Medical College
Division name Plastic and Reconstructive Surgery
Zip code
Address 2-7, Daigaku-cho, Takatsuki City, Osaka Japan
TEL 072-683-1221
Email pla042@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nuri
Organization Osaka Medical College
Division name Plastic and Reconstructive surgery
Zip code
Address 2-7, Daigaku-cho, Takatsuki, Osaka, Japan
TEL 072-683-1221
Homepage URL
Email pla042@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Osaka Medical College
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
Email

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 04 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
2012 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 12 Month 09 Day
Last modified on
2013 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014664

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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