Clinical trial · Observational
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)
A prospective study will be conducted to assess the outcomes of patients who underwent concurrent robotic-assisted mastectomy and robotic-assisted free DIEP flap harvest for breast reconstruction between March 2020 and June 25, 2023. Demographic data, including age, body mass index (BMI), and medical history, were collected, along with surgical time and perioperative parameters. The incidence of acute and chronic complications was documented.
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 |
| Breast Reconstruction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oncoplastic Entirely Robot-Assisted Approach (OPERA) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study group
- description
- Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction.
- interventionNames
- Procedure: Oncoplastic Entirely Robot-Assisted Approach (OPERA)
Primary outcomes (3)
- measure
- Re-open
- timeFrame
- Post-operative 14 days
- description
- Whether the patient return to the operation room to check the blood flow or re-do the anastomosis.
- measure
- Acute complication (< 30 days)
- timeFrame
- Post-operative 30 days
- measure
- Chronic complication (> 30 days)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction Exclusion Criteria: * None
References
Publications (0)
Data not yet available