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
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
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
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
