Breast ReconstructionNCT06321549
New Era of DIEP With Minimally Invasive Mastectomy
An observational study of Breast Reconstruction and Mastectomy; Lymphedema, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The free deep inferior epigastric artery perforator (DIEP) flap is the gold standard in autologous breast reconstruction. Asian patients often present with a smaller body mass index with relatively insufficient tissue. To restore appropriate symmetry, a larger flap inset ratio must be transferred. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Reconstruction, Mastectomy; Lymphedema
- What is being tested?
- The reference point of minimally invasive mastectomy procedure conducted
- How many people
- 278 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Oct 2022to 2 Oct 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: All patients who underwent breast reconstruction procedures with DIEP flaps from October 2008 to March 2022 from a single experienced reconstructive surgeon's practice at a medical institution.
Who may be able to join
- All patients who underwent breast reconstruction procedures with DIEP flaps from October 2008 to March 2022.
- Patients who have a minimum follow-up duration of six months post-reconstruction.
Who cannot join
- Patients who did not meet the six-month follow-up duration was excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shifting Strategic Approach in Breast Reconstruction Using Free DIEP Flap Along With The Paradigm Shifting of Mastectomy Technique
The free deep inferior epigastric artery perforator (DIEP) flap is the gold standard in autologous breast reconstruction. Asian patients often present with a smaller body mass index with relatively insufficient tissue. To restore appropriate symmetry, a larger flap inset ratio must be transferred. Supercharging of the second vein or inclusion of bilateral pedicle is commonly required. Current paradigm shifts in mastectomy has also resulted in more minimally invasive surgeries (MIS) espousing smaller lateral incisions, leading to a significant change in available recipient vessels. This study aimed to demonstrate our experience in changing strategies of DIEP flaps following the evolution of mastectomy techniques.
Between October 2008 and March 2022, retrospective data was gathered for 278 patients who underwent breast reconstruction surgery utilizing DIEP flaps by a single plastic surgeon. These patients were divided into two distinct groups based on their operation dates, with November 2018 marking a pivotal moment when the first MIS was introduced.
- Conditions
- Breast Reconstruction, Mastectomy; Lymphedema
- Being tested
- The reference point of minimally invasive mastectomy procedure conducted
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The reference point of minimally invasive mastectomy procedure conductedOther
November 2018 as a temporal reference point was predicated on the milestone of the medical center's inaugural minimally invasive mastectomy procedure conducted
| Study group | Role | What they receive |
|---|---|---|
| Group A | Individuals who underwent surgery prior to November 2018 | |
| Group B | Individuals who underwent surgery after November 2018 Receives: Other: The reference point of minimally invasive mastectomy procedure conducted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopy mastectomy
Measured: Post-operative day 0
Robotic mastectomy
Measured: Post-operative day 0
Incision
Measured: Post-operative day 0
Usage of SIEV
Measured: Post-operative day 0
Inclusion of bipedicle
Measured: Post-operative day 0
Location of recipient artery/vein
Measured: Post-operative day 0
Recipient artery/vein selection
Measured: Post-operative day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start3 Oct 2022
- Primary completion2 Oct 2023
- Study completion2 Oct 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
- 278 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
- Investigators
- Jung-Ju Huang, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321549
- Sponsor's protocol ID
- 202201562B0
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin TE, Wong AW, Cheong DC, Kuo WL, Tsai HP, Huang JJ. Strategically shifting paradigms: the new era of DIEP flaps with minimally invasive mastectomy: a retrospective cross-sectional study. BMC Cancer. 2024 Aug 30;24(1):1072. doi: 10.1186/s12885-024-12846-x.
PubMed 39210299
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shifting Strategic Approach in Breast Reconstruction Using Free DIEP Flap Along With The Paradigm Shifting of Mastectomy Technique
- ClinicalTrials.gov ID
- NCT06321549
- Acronym / sponsor ID
- 202201562B0
- Conditions
- Breast Reconstruction, Mastectomy; Lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 20 Mar 2024 (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.
The free deep inferior epigastric artery perforator (DIEP) flap is the gold standard in autologous breast reconstruction. Asian patients often present with a smaller body mass index with relatively insufficient tissue. To restore appropriate symmetry, a larger flap inset ratio must be transferred. Supercharging of the second vein or inclusion of bilateral pedicle is commonly required. Current paradigm shifts in mastectomy has also resulted in more minimally invasive surgeries (MIS) espousing smaller lateral incisions, leading to a significant change in available recipient vessels. This study aimed to demonstrate our experience in changing strategies of DIEP flaps following the evolution of mastectomy techniques.
Between October 2008 and March 2022, retrospective data was gathered for 278 patients who underwent breast reconstruction surgery utilizing DIEP flaps by a single plastic surgeon. These patients were divided into two distinct groups based on their operation dates, with November 2018 marking a pivotal moment when the first MIS was introduced.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Individuals who underwent surgery prior to November 2018 |
| Group B | – | Other: The reference point of minimally invasive mastectomy procedure conductedIndividuals who underwent surgery after November 2018 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent breast reconstruction procedures with DIEP flaps from October 2008 to March 2022 from a single experienced reconstructive surgeon's practice at a medical institution.
Key inclusion criteria (2 listed)
- All patients who underwent breast reconstruction procedures with DIEP flaps from October 2008 to March 2022.
- Patients who have a minimum follow-up duration of six months post-reconstruction.
Key exclusion criteria (1 listed)
- Patients who did not meet the six-month follow-up duration was 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The reference point of minimally invasive mastectomy procedure conductedNovember 2018 as a temporal reference point was predicated on the milestone of the medical center's inaugural minimally invasive mastectomy procedure conducted | Other | Group B |
Primary outcome
Endoscopy mastectomy
Time frame: Post-operative day 0
Robotic mastectomy
Time frame: Post-operative day 0
Incision
Time frame: Post-operative day 0
Usage of SIEV
Time frame: Post-operative day 0
Inclusion of bipedicle
Time frame: Post-operative day 0
Location of recipient artery/vein
Time frame: Post-operative day 0
Recipient artery/vein selection
Time frame: Post-operative day 0
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 20 Mar 2024.
- Derived from this study: PubMed 39210299Lin TE, Wong AW, Cheong DC, Kuo WL, Tsai HP, Huang JJ. Strategically shifting paradigms: the new era of DIEP flaps with minimally invasive mastectomy: a retrospective cross-sectional study. BMC Cancer. 2024 Aug 30;24(1):1072. doi: 10.1186/s12885-024-12846-x.
- Individual participant dataSharing planned: No
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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.
Jung-Ju Huang, MD principal investigator
Chang Gung Memorial Hospital
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 Mastectomy; Lymphedema, 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 2 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 20 Mar 2024. 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?
Endoscopy mastectomy (time frame: Post-operative day 0). The study lists 7 primary outcomes in all. 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 NCT06321549, 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 20 Mar 2024.