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OPERA - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction

Oncoplastic Entirely Robot-Assisted Approach (OPERA) - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06415526
Enrollment
14
Registered
2024-05-16
Start date
2024-05-03
Completion date
2024-05-10
Last updated
2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Mastectomy; Lymphedema

Brief 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 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.

Interventions

PROCEDUREOPERA

Robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 80 Years

Inclusion criteria

* 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

Exclusion criteria

* Patients with previous pelvis surgeries (except C-section)

Design outcomes

Primary

MeasureTime frameDescription
ARS incisionIntra-operativeThe length of incision on anterior rectus sheath
Robotic timeIntra-operativeThe time it took to dissect pedicles with robotic arms
Flap sizeIntra-operativeThe weight of the flap harvested

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026