UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017768
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Obsterics 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
Institute The University of Tokyo Hospital
Institute
Department

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
URL(English) https://upload.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


Contact us.