UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056764 |
|---|---|
| Receipt number | R000064697 |
| Scientific Title | The addition of a process of dissecting the fatty tissue of the breast and pectoralis major muscle using an energy device in total mastectomy for breast cancer: Observation study |
| Date of disclosure of the study information | 2025/01/25 |
| Last modified on | 2025/01/20 19:47:37 |
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Basic information
Public title
The addition of a process of dissecting the fatty tissue of the breast and pectoralis major muscle using an energy device in total mastectomy for breast cancer: Observation study
Acronym
The addition of a process of dissecting the fatty tissue of the breast and pectoralis major muscle using an energy device in total mastectomy for breast cancer: Observation study
Scientific Title
The addition of a process of dissecting the fatty tissue of the breast and pectoralis major muscle using an energy device in total mastectomy for breast cancer: Observation study
Scientific Title:Acronym
The addition of a process of dissecting the fatty tissue of the breast and pectoralis major muscle using an energy device in total mastectomy for breast cancer: Observation study
Region
| Japan |
Condition
Condition
breast cancer patients who received total mastectomy
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the amount of drainage, the frequency of occurrence of seroma in cases of total mastectomy with surgical dissection of the pectoralis fascia using an energyl device.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome: total amount until drain removal; Secondary outcomes: daily drain fluid output, operation time, blood loss, length of hospital stay, frequency of adverse events requiring intervention.
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
The following criteria must all be met.
1) Patients who have been diagnosed with breast cancer histopathologically
2) Patients who have undergone a total mastectomy and whose pectoralis major muscle was separated from the mammary fat tissue using a energy device
*Subcutaneous total mastectomy is almost the same as a total mastectomy and is included in the total mastectomy category.
Key exclusion criteria
Exclusion criteria:
Patients who meet any of the following criteria will be excluded from the study.
1) Patients who received preoperative systemic therapy
2) Patients who received preoperative radiation therapy
3) Patients who have opted out of the study by submitting a published opt-out document
Target sample size
219
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shima |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
S1, W16, Chuo-ki, Sapporo City
TEL
011-611-2111
simahiro@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shima |
Organization
Department of Surgery, Surgical Oncology and Science, Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science, Sapporo Medical University
Zip code
060-8543
Address
S1, W16, Chuo-ki, Sapporo City
TEL
011-611-2111
Homepage URL
simahiro@sapmed.ac.jp
Sponsor or person
Institute
Department of Surgery, Surgical Oncology and Science, Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Surgical Oncology and Science, Sapporo Medical University
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
Clinical Trial Center, Sapporo Medical University
Address
S1, W16, Chuo-ku, Sapporo city
Tel
011-611-2111
simahiro@sapmed.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 | 01 | Month | 25 | 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
158
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
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | 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 comparison with historical data.
(Data from 1 January 2019 to 31 December 2019, which was obtained using the conventional surgical method of performing the operation with an electric scalpel, not a sealing device)
Management information
Registered date
| 2025 | Year | 01 | Month | 20 | Day |
Last modified on
| 2025 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064697
