Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Mastectomy; Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OPERA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- OPERA group
- description
- Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction
- interventionNames
- Procedure: OPERA
Primary outcomes (3)
- measure
- ARS incision
- timeFrame
- Intra-operative
- description
- The length of incision on anterior rectus sheath
- measure
- Robotic time
- timeFrame
- Intra-operative
- description
- The time it took to dissect pedicles with robotic arms
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDKuo 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. PMID 40261832