UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012530
Receipt number 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 16:36:08

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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 or person

Institute

Osaka Medical College

Institute

Department

Personal name



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

Value
https://center6.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