UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008313 |
|---|---|
| Receipt number | R000009790 |
| Scientific Title | Study for the lymphatic function before and afterlymph node dissection for gynecological cancer |
| Date of disclosure of the study information | 2012/07/02 |
| Last modified on | 2012/07/01 18:14:23 |
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Basic information
Public title
Study for the lymphatic function before and afterlymph node dissection for gynecological cancer
Acronym
Study for the lymphatic function before and afterlymph node dissection for gynecological cancer
Scientific Title
Study for the lymphatic function before and afterlymph node dissection for gynecological cancer
Scientific Title:Acronym
Study for the lymphatic function before and afterlymph node dissection for gynecological cancer
Region
| Japan |
Condition
Condition
Secondary Lymphedema
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the lymphatic function following lymph node dissection and the effect of the treatment for the lymphedema
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the lymphatic function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
lymphatiovenular anastmosis
Interventions/Control_2
compression hosiery
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
Female
Key inclusion criteria
gynecological cancer patients who underwent surgery, including pelvic or pelvic and para-aortic lymph node dissection, at Chiba University Hospital
Key exclusion criteria
Iodine allergy, pregnancy, recurrence after previous surgery, and psychiatric disorders. In addition, patients who lost the ability to walk or patients with poor prognosis in the early postoperative period following lymphadenectomy were also excluded, even if they had been included preoperatively.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaneshige Satoh |
Organization
Chiba University
Division name
Plastic Surgery
Zip code
Address
1-8-1, Inonana, Chuo-ku, Chiba City, Chiba, 260-8677 Japan
TEL
043262316
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Akita |
Organization
Chiba University
Division name
Plastic Surgery
Zip code
Address
1-8-1, Inonana, Chuo-ku, Chiba City, Chiba, 260-8677 Japan
TEL
0432262316
Homepage URL
sakita-chiba@umin.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
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
| 2012 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2002 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | 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
| 2012 | Year | 07 | Month | 01 | Day |
Last modified on
| 2012 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009790
