UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017768
Receipt number R000020582
Scientific Title Study of the effectiveness of early lymphatic venous anastomosis (early lymphatic venous anastomosis for patients with uterine cancer hysterectomy and lymph node dissection after surgery)
Date of disclosure of the study information 2015/06/02
Last modified on 2015/06/02 08:26:15

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Basic information

Public title

Study of the effectiveness of early lymphatic venous anastomosis (early lymphatic venous anastomosis for patients with uterine cancer hysterectomy and lymph node dissection after surgery)

Acronym

Study of the effectiveness of early lymphatic venous anastomosis

Scientific Title

Study of the effectiveness of early lymphatic venous anastomosis (early lymphatic venous anastomosis for patients with uterine cancer hysterectomy and lymph node dissection after surgery)

Scientific Title:Acronym

Study of the effectiveness of early lymphatic venous anastomosis

Region

Japan


Condition

Condition

lymphedema

Classification by specialty

Medicine in general Obstetrics and Gynecology Radiology
Plastic surgery Adult Child

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Effectiveness of early intervention of lymphedema patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Circumference of the leg (LEL index)
The presence or absence of cellulitis

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

LVA

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

0 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Secondary lymphedema patients

Key exclusion criteria

Primary lymphedema patients
Varicose Veins
The lower limb edema patients with other causes

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name koshima Isao

Organization

University of Tokyo Hospital

Division name

Plastic and Reconstructive surgery

Zip code


Address

7-3-1Hongo Bunkyoku Tokyo Japan

TEL

03-5800-8670

Email

koushimai-pla@h.u-tokyo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koshima Isao

Organization

University of Tokyo Hospital

Division name

Plastic and Reconstructive surgery

Zip code


Address

7-3-1Hongo Bunkyoku Tokyo Japan

TEL

03-5800-8670

Homepage URL


Email

koushimai-pla@h.u-tokyo.ac.jp


Sponsor or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

The University of Tokyo Hospital
Plastic and Reconstructive surgery

Organization

Division

Category of Funding Organization

Self funding

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

2015 Year 06 Month 02 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

2009 Year 01 Month 13 Day

Date of IRB


Anticipated trial start date

2009 Year 01 Month 14 Day

Last follow-up date

2019 Year 01 Month 12 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 06 Month 02 Day

Last modified on

2015 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020582


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name