UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061413 |
|---|---|
| Receipt number | R000070271 |
| Scientific Title | A Study of the Incidence of Postoperative Lymphoedema and Associated Factors |
| Date of disclosure of the study information | 2026/04/30 |
| Last modified on | 2026/04/30 11:22:34 |
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Basic information
Public title
A Study of the Incidence of Postoperative Lymphoedema and Associated Factors
Acronym
Incidence of Lymphoedema and Associated Factors
Scientific Title
A Study of the Incidence of Postoperative Lymphoedema and Associated Factors
Scientific Title:Acronym
Incidence of postoperative lymphoedema and associated factors
Region
| Japan |
Condition
Condition
Patients who have undergone lymph node dissection
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a retrospective analysis of the assessment results obtained from clinical pathways and to investigate the incidence of postoperative lymphoedema and its associated factors
Basic objectives2
Others
Basic objectives -Others
incidence rate
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Circumference of the limbs
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who were admitted to the breast surgery/gynecology ward at Fujita Health University Hospital, became eligible for a clinical pathway between May 2014 and April 2020, and were referred to the rehabilitation department.
Key exclusion criteria
Patients for whom sufficient necessary data cannot be obtained due to incomplete or incorrect data.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
koyamas@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Soichiro |
| Middle name | |
| Last name | Koyama |
Organization
Fujita Health University
Division name
Faculty of Rehabilitation, School of Health Sciences
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-9000
Homepage URL
koyamas@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health 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
Institutional Review Board of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2026 | Year | 04 | Month | 30 | 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
600
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Opt-out consent was obtained instead of written informed consent, which was approved by the Ethics Committee of Fujita Health University. We provided patients with information explaining the proposed research plan via the website of Fujita Health University School of Medicine, and gave them the opportunity to opt-out.
Management information
Registered date
| 2026 | Year | 04 | Month | 30 | Day |
Last modified on
| 2026 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070271
