UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058748 |
|---|---|
| Receipt number | R000067173 |
| Scientific Title | A Retrospective Study on Treatment Outcomes for Lymphedema and Lymphatic Disorders |
| Date of disclosure of the study information | 2025/08/09 |
| Last modified on | 2025/08/09 12:20:19 |
* 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
A Retrospective Study on Treatment Outcomes for Lymphedema and Lymphatic Disorders
Acronym
A Retrospective Study on Treatment Outcomes for Lymphedema and Lymphatic Disorders
Scientific Title
A Retrospective Study on Treatment Outcomes for Lymphedema and Lymphatic Disorders
Scientific Title:Acronym
A Retrospective Study on Treatment Outcomes for Lymphedema and Lymphatic Disorders
Region
| Japan |
Condition
Condition
Lymphedema and Lymphatic Disorders
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively analyze treatment outcomes for lymphedema and other lymphatic disorders at our institution, and to evaluate the usefulness and validity of our diagnostic and therapeutic approaches.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in clinical symptoms and anthropometric measurements before and after treatment (e.g., limb circumference, severity of edema, skin changes)
Changes in functional status (e.g., activities of daily living [ADL] scores, patient-reported outcomes)
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
Patients who visited the Mukumi Clinic between November 1, 2018, and March 31, 2025, and were diagnosed with lymphedema or other lymphatic disorders.
Key exclusion criteria
1. Patients deemed unsuitable for inclusion in the study by the principal investigator.
2. Patients who declined to participate in the study.
Target sample size
989
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Mihara |
Organization
Mukumi Clinic
Division name
Clinical Department
Zip code
151-0053
Address
3F, toDOe Yoyogi Building, 1-35-3 Yoyogi, Shibuya-ku, Tokyo, 151-0053, Japan
TEL
050-3146-4579
mihara.plasticsurgery@gmail.com
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Mihara |
Organization
Clinical Department
Division name
Clinical Department
Zip code
151-0053
Address
3F, toDOe Yoyogi Building, 1-35-3 Yoyogi, Shibuya-ku, Tokyo, 151-0053, Japan
TEL
050-3146-4579
Homepage URL
mihara.plasticsurgery@gmail.com
Sponsor or person
Institute
Mukumi Clinic
Institute
Department
Personal name
Funding Source
Organization
Non
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
Ethics Review Committee, Aichi Medical University
Address
1-1 Yazako Karimata, Nagakute, Aichi 480-1195, Japan
Tel
0561-62-3311
amu_crb@aichi-med-u.ac.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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 09 | 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
1000
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
Completed
Date of protocol fixation
| 2025 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center, retrospective observational study.
The study will include patients who visited Mukumi Clinic between November 1, 2018, and March 31, 2025, and were diagnosed with lymphedema or other lymphatic disorders.
Medical records will be reviewed to evaluate the usefulness and validity of diagnostic and therapeutic approaches.
Management information
Registered date
| 2025 | Year | 08 | Month | 09 | Day |
Last modified on
| 2025 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067173
