Breast ReconstructionNCT05943873
Successful Microsurgical Breast Reconstruction in Minimally Invasive Mastectomy
An observational study of Breast Reconstruction and Breast Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
A retrospective chart review will be conducted to identify patients who received breast reconstruction surgery with DIEP flaps by a single plastic surgeon in one medical center between November 2018 and July 2022. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Reconstruction, Breast Cancer
- How many people
- 63 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jun 2023to 5 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who received nipple sparing mastectomy and breast reconstruction from November 2018 to July 2022 from a single breast reconstruction surgeon
Who may be able to join
- patients who received nipple sparing mastectomy and breast reconstruction from November 2018 to July 2022 from a single breast reconstruction surgeon.
Who cannot join
- patients failed to be examined for outcome evaluation will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Six Steps for a Successful Aesthetic Free Flap Reconstruction Shaping After Minimally Invasive Mastectomy
A retrospective chart review will be conducted to identify patients who received breast reconstruction surgery with DIEP flaps by a single plastic surgeon in one medical center between November 2018 and July 2022. Patients will be grouped based on how the mastectomy was performed, via minimally invasive or conventional approach. Demographic data, flap profile, vessel anastomosis and post-operative complication will be retrospectively reviewed. Data collection includes patient demographics, previous breast surgical history, breast cancer history and adjuvant therapy, surgical details and postoperative events.
- Conditions
- Breast Reconstruction, Breast Cancer
- Keywords
- free flap, breast reconstruction, minimally invasive mastectomy, nipple-sparing mastectomy, robotic-assisted mastectomy, endoscopic-assisted mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Conventional mastectomy | |
| Minimally invasive | robotic-assisted or endoscopic assisted mastectomies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful
If the free flap transferred is successfully survived
Measured: post-operative 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start30 Jun 2023
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Ju Huang, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943873
- Sponsor's protocol ID
- 202300895B0
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wong AW, Kuo WL, Cheong DC, Tsai HP, Kao SW, Chen CF, Huang JJ. Six steps for a successful aesthetic free flap reconstruction after minimally invasive mastectomy: a retrospective case-control study. Int J Surg. 2024 Feb 1;110(2):645-653. doi: 10.1097/JS9.0000000000000871.
PubMed 38000051
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Six Steps for a Successful Aesthetic Free Flap Reconstruction Shaping After Minimally Invasive Mastectomy
- ClinicalTrials.gov ID
- NCT05943873
- Acronym / sponsor ID
- 202300895B0
- Conditions
- Breast Reconstruction, Breast Cancer
- Keywords
- free flap, breast reconstruction, minimally invasive mastectomy, nipple-sparing mastectomy, robotic-assisted mastectomy, endoscopic-assisted mastectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A retrospective chart review will be conducted to identify patients who received breast reconstruction surgery with DIEP flaps by a single plastic surgeon in one medical center between November 2018 and July 2022. Patients will be grouped based on how the mastectomy was performed, via minimally invasive or conventional approach. Demographic data, flap profile, vessel anastomosis and post-operative complication will be retrospectively reviewed. Data collection includes patient demographics, previous breast surgical history, breast cancer history and adjuvant therapy, surgical details and postoperative events.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Conventional mastectomy |
| Minimally invasive | – | –robotic-assisted or endoscopic assisted mastectomies |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who received nipple sparing mastectomy and breast reconstruction from November 2018 to July 2022 from a single breast reconstruction surgeon
Key inclusion criteria (1 listed)
- patients who received nipple sparing mastectomy and breast reconstruction from November 2018 to July 2022 from a single breast reconstruction surgeon.
Key exclusion criteria (1 listed)
- patients failed to be examined for outcome evaluation will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Successful
Time frame: post-operative 7 days
If the free flap transferred is successfully survived
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Derived from this study: PubMed 38000051Wong AW, Kuo WL, Cheong DC, Tsai HP, Kao SW, Chen CF, Huang JJ. Six steps for a successful aesthetic free flap reconstruction after minimally invasive mastectomy: a retrospective case-control study. Int J Surg. 2024 Feb 1;110(2):645-653. doi: 10.1097/JS9.0000000000000871.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Reconstruction and Breast Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful (time frame: post-operative 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05943873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.