UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059023 |
|---|---|
| Receipt number | R000067501 |
| Scientific Title | Retrospective Analysis of Surgical Treatment of Lymphedema |
| Date of disclosure of the study information | 2025/09/07 |
| Last modified on | 2025/09/07 08:57:28 |
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Basic information
Public title
Retrospective Analysis of Surgical Treatment of Lymphedema
Acronym
Retrospective Analysis of Surgical Treatment of Lymphedema
Scientific Title
Retrospective Analysis of Surgical Treatment of Lymphedema
Scientific Title:Acronym
Retrospective Analysis of Surgical Treatment of Lymphedema
Region
| Japan |
Condition
Condition
Lymphedema
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to collect and analyze postoperative data on lymphedema patients.
Basic objectives2
Others
Basic objectives -Others
Exploration
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between Surgical Procedure and Postoperative Circumference
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with lymphedema who underwent surgical treatment for lymphedema.
2. Patients diagnosed with lymphedema who declined surgical treatment and are currently under observation.
Key exclusion criteria
1. Cases where the subject or their authorized representative expressed refusal to participate in this study
2. Other cases deemed unsuitable as research subjects by the responsible investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Kishi |
Organization
Keio University School of Medicine
Division name
Department of Plastic and Reconstructive surgery
Zip code
1608582
Address
Shinanomachi 35 Shinjuku
TEL
0353633814
kkishi@keio.jp
Public contact
Name of contact person
| 1st name | Yushi |
| Middle name | |
| Last name | Suzuki |
Organization
Keio University School of Medicine
Division name
Department of Plastic and Reconstructive surgery
Zip code
1608582
Address
Shinanomachi 35 Shinjuku
TEL
0353633814
Homepage URL
fi080150@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Kazuo Kishi
Funding Source
Organization
Keio 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
Keio University School of Medicine
Address
Shinanomachi 35
Tel
0353633814
fi080150@keio.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 07 | 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
| 2022 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study includes patients who underwent surgical treatment for lymphedema. For these patients, we will compare the surgical site, number of procedures performed, surgical technique, postoperative circumference and firmness, incidence of cellulitis, changes in fluid volume, and changes in subjective symptoms.
Additionally, for patients who underwent surgery prior to the study approval date and for whom these data have already been collected, consent will be obtained via an opt-out approach.
Management information
Registered date
| 2025 | Year | 09 | Month | 07 | Day |
Last modified on
| 2025 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067501
