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

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.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, 33305, Taiwan

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

OPERA

Procedure

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

Primary outcomes

ARS incision

Time frame: Intra-operative

The length of incision on anterior rectus sheath
Robotic time

Time frame: Intra-operative

The time it took to dissect pedicles with robotic arms
Flap size

Time frame: Intra-operative

The weight of the flap harvested

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: May 16, 2024
Registry last updated: May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed