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

Last updated: May 10, 2024
Sponsor: Chang Gung Memorial Hospital
Overall Status: Completed

Phase

N/A

Condition

Breast Cancer

Lymphedema

Cancer

Treatment

OPERA

Clinical Study ID

NCT06415526
202400581B0
  • Ages 20-80
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with ASA (American Society of Anesthesiologist) classification 1-2

  • Breast skin should be free from cancer involvement, with adequate tumor to skindistance, 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, atleast 1 cm distance between the lesion and the nipple

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 14
Treatment Group(s): 1
Primary Treatment: OPERA
Phase:
Study Start date:
May 03, 2024
Estimated Completion Date:
May 10, 2024

Connect with a study center

  • Chang Gung Memorial Hospital

    Taoyuan, 33305
    Taiwan

    Site Not Available

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