UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046344 |
|---|---|
| Receipt number | R000052879 |
| Scientific Title | Comparison of short-term outcomes between pedicled- and free-flap autologous breast reconstruction |
| Date of disclosure of the study information | 2021/12/10 |
| Last modified on | 2021/12/10 07:57:20 |
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Basic information
Public title
Comparison of short-term outcomes between pedicled- and free-flap autologous breast reconstruction
Acronym
Comparison of short-term outcomes between pedicled- and free-flap autologous breast reconstruction
Scientific Title
Comparison of short-term outcomes between pedicled- and free-flap autologous breast reconstruction
Scientific Title:Acronym
Comparison of short-term outcomes between pedicled- and free-flap autologous breast reconstruction
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the complications after pedicled- or free-flap breast reconstruction.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the occurrence of postoperative complications
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
Female
Key inclusion criteria
Using a Japanese national inpatient database, we identified female patients with breast cancer who underwent breast reconstruction using a pedicled flap or free flap between July 2010 and March 2020.
Key exclusion criteria
We excluded patients with stage IV breast cancer because surgery is not a standard treatment for stage IV breast cancer.
Target sample size
13000
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | Karakawa |
| Last name | Karakawa |
Organization
Caner Institute Hospital
Division name
Plastic and Reconstructive Surgery
Zip code
135-8550
Address
3-8-31, Ariake, Koto-ku,
TEL
0335200111
ryo.kyara@gmail.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Karakawa |
Organization
Caner Institute Hospital
Division name
Plastic and Reconstructive Surgery
Zip code
135-8550
Address
3-8-31, Ariake, Koto-ku,
TEL
0335200111
Homepage URL
ryo.kyara@gmail.com
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
| 2021 | Year | 12 | Month | 10 | 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
13000
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
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This nationwide retrospective cohort study was performed using the Diagnosis Procedure Combination database, which includes hospital administrative claims data and discharge abstracts of approximately 7,000,000 inpatients in more than 1000 hospitals throughout Japan [26, 27], covering approximately half of all inpatient admissions to acute-care hospitals in Japan. All 82 university hospitals are obliged to participate in the database; participation by community hospitals is voluntary.
Management information
Registered date
| 2021 | Year | 12 | Month | 10 | Day |
Last modified on
| 2021 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052879
