OPERA - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction

NCT06415526 | Completed

• 1 other identifier: 202400581B0
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Mastectomy; Lymphedema

Outcome Measures

Primary Outcomes (3)

• ARS incision

  The length of incision on anterior rectus sheath

  Intra-operative

• Robotic time

  The time it took to dissect pedicles with robotic arms

  Intra-operative

• Flap size

  The weight of the flap harvested

  Intra-operative

Study Arms (1)

OPERA group

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

Procedure: OPERA

Interventions

OPERA PROCEDURE

Robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction

OPERA group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patients with previous pelvis surgeries (except C-section)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

Related Publications (1)

• Kuo 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: May 3, 2024
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)