OPERA - 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: NCT06415526
• Other study ID #: 202400581B0
• Status: Completed
• Start date: May 3, 2024
• Est. completion date: May 10, 2024

Study information

• Verified date: May 2024
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 10, 2024
• Est. primary completion date: May 10, 2024
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Lymphedema
• Mastectomy; Lymphedema

Intervention

Procedure:
• OPERA
Robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction

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	ARS incision	The length of incision on anterior rectus sheath	Intra-operative
Primary	Robotic time	The time it took to dissect pedicles with robotic arms	Intra-operative
Primary	Flap size	The weight of the flap harvested	Intra-operative