UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047153 |
|---|---|
| Receipt number | R000053780 |
| Scientific Title | A retrospective observational study of vascular anatomy, blood flow, breast morphology, and complications of breast reconstruction with deep Inferior epigastric artery perforator flap |
| Date of disclosure of the study information | 2022/03/11 |
| Last modified on | 2023/04/12 11:31:05 |
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Basic information
Public title
Study of vascular anatomy, blood flow evaluation, breast morphology evaluation, and complications in breast reconstruction with abdominal perforator flap
Acronym
Vascular anatomy, blood flow evaluation, complications, and morphology evaluation of DIEP flap breast reconstruction
Scientific Title
A retrospective observational study of vascular anatomy, blood flow, breast morphology, and complications of breast reconstruction with deep Inferior epigastric artery perforator flap
Scientific Title:Acronym
clinical anatomy, hemodynamic analysis and complications of the DIEP flap and evaluation of the reconstructed breast
Region
| Japan |
Condition
Condition
Breast cancer: cases of total mastectomy followed by breast reconstruction using a deep inferior epigastric artery perforator flap
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Deep inferior epigastric perforator flap is widely used for breast reconstruction after total mastectomy. Different institutions use different techniques for the same procedure, and there are differences in the number and location of perforators to be included in the transplanted tissue. It is thought that these differences may result in differences in postoperative breast morphology and complication rates, but this is not clear at this time. This study retrospectively examined medical records, preoperative contrast CT, color Doppler echocardiography, and intraoperative indocyanine green (ICG) contrast data to determine the hemodynamics of each perforator in the flap and the postoperative results and complication rates according to the location and number of perforators in the flap, and to identify the safest flap. The objective is to identify the perforating branches necessary for tissue transfer and to improve surgical safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Partial necrosis and partial fat necrosis of the flap in the early postoperative period (3-6 months postoperative) and mid-term (approximately 1 year postoperative)
Key secondary outcomes
Correlation between the number and location of perforating branches included in the flap and early- and mid-term postoperative flap complications in the surgical findings documented in the medical record.
Relationship between the number and location of perforating branches included in the flap and the extent of intraoperative ICG fluorescence contrast of the flap in the surgical findings documented in the medical record.
Evaluation of flap complications and reconstructed breast morphology in the early and mid postoperative period.
Long-term evaluation of the above items will also be performed in cases in which long-term postoperative follow-up (approximately 3 years postoperatively) is possible.
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
Female
Key inclusion criteria
Patients who underwent breast reconstruction with a deep inferior abdominal artery perforator flap at the same time as or secondary to total mastectomy for breast cancer at the institution from January 1, 2011 to December 24, 2021
Key exclusion criteria
Cases with incomplete surgical records.When thr subject declines to participate in the research or withdraws the patient's consent.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | yuichi |
| Middle name | |
| Last name | Ichikawa |
Organization
Juntendo university
Division name
plastic and reconstructive surgery
Zip code
113-8431
Address
3-1-3 Hongo Bunkyoku Tokyo
TEL
03-3813-3111
yuichika@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | meisei |
| Middle name | |
| Last name | takeishi |
Organization
Breast Reconstruction Institut
Division name
plastic and reconstructive surgery
Zip code
411-0023
Address
69-21Kamo Mishima city Shizuoka prefecture
TEL
055-955-8063
Homepage URL
meisei.takeishi@gmail.com
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
none
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
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo Bunkyoku Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.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
静岡県立静岡がんセンター再建・形成外科,愛知県立愛知がんセンター中央病院形成外科,東京医科大学形成外科,南大和病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing special
Management information
Registered date
| 2022 | Year | 03 | Month | 11 | Day |
Last modified on
| 2023 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053780
