Breast CancerNCT06415526
OPERA - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction
An observational study of Breast Cancer and Mastectomy; Lymphedema, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Current breast cancer surgery is achieving minimally invasive approach to reduce incision while providing better surgical vision and freedom in mastectomy. Breast reconstruction with free deep inferior epigastric artery perforator (DIEP) flap was considered the gold standard, however, the donor site morbidity remains… Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Mastectomy; Lymphedema
- What is being tested?
- OPERA
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 May 2024to 10 May 2024
- 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 20 to 80 years
- Women only
- Adult, Older adult
Study population: Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction
Who may be able to join
- Patients with ASA (American Society of Anesthesiologist) classification 1-2
- Breast skin should be free from cancer involvement, with adequate tumor to skin distance, and the largest preoperative tumor size no more than 5 cm
- The lesion should be located in any of the 4 quadrants away from the nipple, at least 1 cm distance between the lesion and the nipple
Who cannot join
- Patients with previous pelvis surgeries (except C-section)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oncoplastic Entirely Robot-Assisted Approach (OPERA) - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction
Current breast cancer surgery is achieving minimally invasive approach to reduce incision while providing better surgical vision and freedom in mastectomy. Breast reconstruction with free deep inferior epigastric artery perforator (DIEP) flap was considered the gold standard, however, the donor site morbidity remains an endless concern. Here we applied robotic-assisted surgery in both mastectomy and free DIEP flap harvest, so-called Oncoplastic Entirely Robot-Assisted Approach (OPERA).
A retrospective chart review identified 14 patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction. The patient demographics and mastectomy and flap characteristics were reviewed.
- Conditions
- Breast Cancer, Mastectomy; Lymphedema
- Being tested
- OPERA
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPERAProcedure or surgery
Robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction
| Study group | Role | What they receive |
|---|---|---|
| OPERA group | Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction Receives: Procedure: OPERA |
What is being measured
The primary outcome is the main question the study is designed to answer.
ARS incision
The length of incision on anterior rectus sheath
Measured: Intra-operative
Robotic time
The time it took to dissect pedicles with robotic arms
Measured: Intra-operative
Flap size
The weight of the flap harvested
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start3 May 2024
- Primary completion10 May 2024
- Study completion10 May 2024
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 CancerStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 14 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
- NCT06415526
- Sponsor's protocol ID
- 202400581B0
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuo WL, Wong AW, Tsai CY, Chen YF, Chang TN, Cheong DC, Huang JJ. Oncoplastic Entirely Robot-Assisted Approach: Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction. Plast Reconstr Surg. 2025 Oct 1;156(4):451e-460e. doi: 10.1097/PRS.0000000000012157. Epub 2025 Apr 21.
PubMed 40261832
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncoplastic Entirely Robot-Assisted Approach (OPERA) - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction
- ClinicalTrials.gov ID
- NCT06415526
- Acronym / sponsor ID
- 202400581B0
- Conditions
- Breast Cancer, Mastectomy; Lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 16 May 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.
Current breast cancer surgery is achieving minimally invasive approach to reduce incision while providing better surgical vision and freedom in mastectomy. Breast reconstruction with free deep inferior epigastric artery perforator (DIEP) flap was considered the gold standard, however, the donor site morbidity remains an endless concern. Here we applied robotic-assisted surgery in both mastectomy and free DIEP flap harvest, so-called Oncoplastic Entirely Robot-Assisted Approach (OPERA).
A retrospective chart review identified 14 patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction. The patient demographics and mastectomy and flap characteristics were reviewed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPERA group | – | Procedure: OPERAPatients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction
Key inclusion criteria (3 listed)
- Patients with ASA (American Society of Anesthesiologist) classification 1-2
- Breast skin should be free from cancer involvement, with adequate tumor to skin distance, and the largest preoperative tumor size no more than 5 cm
- The lesion should be located in any of the 4 quadrants away from the nipple, at least 1 cm distance between the lesion and the nipple
Key exclusion criteria (1 listed)
- Patients with previous pelvis surgeries (except C-section)
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 |
|---|---|---|
| OPERARobotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction | Procedure or surgery | OPERA group |
Primary outcome
ARS incision
Time frame: Intra-operative
The length of incision on anterior rectus sheath
Robotic time
Time frame: Intra-operative
The time it took to dissect pedicles with robotic arms
Flap size
Time frame: Intra-operative
The weight of the flap harvested
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 16 May 2024.
- Derived from this study: PubMed 40261832Kuo WL, Wong AW, Tsai CY, Chen YF, Chang TN, Cheong DC, Huang JJ. Oncoplastic Entirely Robot-Assisted Approach: Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction. Plast Reconstr Surg. 2025 Oct 1;156(4):451e-460e. doi: 10.1097/PRS.0000000000012157. Epub 2025 Apr 21.
- 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.
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 Cancer 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 3 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 16 May 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?
ARS incision (time frame: Intra-operative). The study lists 3 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 NCT06415526, 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 16 May 2024.