UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003538
Receipt number R000004297
Scientific Title The change of SSI ratio after Pancreatoduodenectomy according to a method of rskin closure.
Date of disclosure of the study information 2010/04/27
Last modified on 2016/04/26 12:59:53

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Basic information

Public title

The change of SSI ratio after Pancreatoduodenectomy according to a method of rskin closure.

Acronym

The ratio of SSI after PD

Scientific Title

The change of SSI ratio after Pancreatoduodenectomy according to a method of rskin closure.

Scientific Title:Acronym

The ratio of SSI after PD

Region

Japan


Condition

Condition


patients with PD

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The change of SSi ratio after PD according to a method of skin closeure, damabond vs nylon stich

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

rato of SSI

Key secondary outcomes

hospital stay
Economic effect


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

damabond method

Interventions/Control_2

nylon stich methods

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

18 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

pancreas duct dilatation: yes or no
DM yes or no
age 65 yrs </= or >

Key exclusion criteria

none

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Keiichi Kubota

Organization

Dokkyo Medical University

Division name

Second Department of Surgery

Zip code


Address

880 kitakobayashi, Mibu, Tochigi, Japan

TEL

0282-87-2158

Email

kkubota@dokkyomed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mitsugi Shimoda

Organization

Second Department of Surgery

Division name

Second Department of Surgery

Zip code


Address

880 Kita kobayashi, Mibu, Tochigi, Japan

TEL

0282-87-2158

Homepage URL


Email

shimodamitsugi@hotmail.com


Sponsor or person

Institute

Dokkyo Medical University

Institute

Department

Personal name



Funding Source

Organization

Dokkyo Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Dokkyo Medical University

Name of secondary funder(s)

none


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

獨協医科大学病院


Other administrative information

Date of disclosure of the study information

2010 Year 04 Month 27 Day


Related information

URL releasing protocol

http://www.dokkyomed.ac.jp/dep-m/surg2/index.html

Publication of results

Unpublished


Result

URL related to results and publications

http://www.dokkyomed.ac.jp/dep-m/surg2/index.html

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

2009 Year 02 Month 03 Day

Date of IRB


Anticipated trial start date

2009 Year 03 Month 01 Day

Last follow-up date

2010 Year 04 Month 01 Day

Date of closure to data entry

2014 Year 03 Month 01 Day

Date trial data considered complete

2015 Year 03 Month 01 Day

Date analysis concluded

2015 Year 07 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 04 Month 26 Day

Last modified on

2016 Year 04 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004297


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name