CompletedNot Applicable

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

Taiwan14 participantsStarted 2024-05-03

Plain-language 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.

Who can participate

Age range20 Years – 80 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

ARS incision

Timeframe: Intra-operative

Robotic time

Timeframe: Intra-operative

Flap size

Timeframe: Intra-operative

Trial details

NCT IDNCT06415526

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-05-10

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