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NCT05945914 Clinical Trial

Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction

Breast Cancer Clinical Trial

Official title:
Oncoplastic Entirely Robot-Assisted Approach (OPERA) - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05945914
Other study ID # 202300888B0
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 30, 2023
Est. completion date July 7, 2023

Study information
Verified date July 2023
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date July 7, 2023
Est. primary completion date July 7, 2023
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Taiwan Chang Gung Memorial Hospital Taoyuan

Sponsors (1)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Re-open Whether the patient return to the operation room to check the blood flow or re-do the anastomosis. Post-operative 14 days
Primary Acute complication (< 30 days) Post-operative 30 days
Primary Chronic complication (> 30 days) One year after surgery
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