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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05945914
Enrollment
9
Registered
2023-07-14
Start date
2023-06-30
Completion date
2023-07-07
Last updated
2023-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Breast Reconstruction

Brief summary

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.

Interventions

PROCEDUREOncoplastic Entirely Robot-Assisted Approach (OPERA)

Robotic-assisted surgery in both mastectomy and free DIEP flap harvest, so-called Oncoplastic Entirely Robot-Assisted Approach (OPERA).

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Re-openPost-operative 14 daysWhether the patient return to the operation room to check the blood flow or re-do the anastomosis.
Acute complication (< 30 days)Post-operative 30 days
Chronic complication (> 30 days)One year after surgery

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026