UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056374 |
|---|---|
| Receipt number | R000064413 |
| Scientific Title | Breast reconstruction assisted by endoscopic abdominal perforator flap |
| Date of disclosure of the study information | 2025/01/15 |
| Last modified on | 2024/12/05 22:05:57 |
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Basic information
Public title
Breast reconstruction assisted by endoscopic abdominal perforator flap
Acronym
Breast reconstruction assisted by endoscopic abdominal perforator flap
Scientific Title
Breast reconstruction assisted by endoscopic abdominal perforator flap
Scientific Title:Acronym
Breast reconstruction assisted by endoscopic abdominal perforator flap
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effectiveness and safety of DIEP flap (deep inferior epigastric artery perforator flap) elevation using an endoscope.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety evaluation (incidence of adverse events)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The DIEP flap is raised under endoscopic assistance for early-stage breast cancer patients who desire breast reconstruction.
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
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
1. 20 years old or over, under 75 years old
2. Breast cancer patients
3. Patients who will undergo or have already undergone a mastectomy
4. Patients who meet the criteria for DIEP flap
5. Patients whose doctors have determined, based on abdominal contrast CT, that the blood vessels within the muscles are simple in their course
6. Patients who do not have serious complications
Key exclusion criteria
1. Patients with a history of abdominal surgery who are judged to have difficulty with endoscopic manipulation
Reason: To avoid technical difficulties caused by adhesions around blood vessels
2. Patients with a BMI of 35 or more who are severely obese
Reason: To avoid complications caused by long-duration surgery and to avoid technical difficulties
3. Patients taking antithrombotic medication
Reason: To avoid postoperative bleeding in the muscle sheath
4. Patients judged by the attending physician to be unsuitable
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ryohei |
| Middle name | |
| Last name | Katsuragi |
Organization
Nakagami hospital
Division name
Breast Surgery
Zip code
904-2143
Address
610 Noborikawa, Okinawa City, Okinawa Prefecture, Japan
TEL
0989391300
ryohei2936@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Katsuragi |
Organization
Nakagami Hospital
Division name
Brest surgery
Zip code
930-0882
Address
610 Noborikawa, Okinawa City, Okinawa Prefecture, Japan
TEL
0989391300
Homepage URL
ryohei2936@yahoo.co.jp
Sponsor or person
Institute
Nakagami hospital
Institute
Department
Personal name
Ryohei Katsuragi
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
Nakagami Hospital
Address
610 Noborikawa, Okinawa City, Okinawa Prefecture, Japan
Tel
0989391300
ryohei2936@yahoo.co.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 | 15 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 05 | Day |
Last modified on
| 2024 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064413
