Oncoplastic Entirely Robot-Assisted Approach (OPERA) - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Flap size
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Flap size
Time Frame: Intra-operative
The weight of the flap harvested
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Jung-Ju Huang
Associate Professor
Chang Gung Memorial Hospital