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

Completed

• Conditions: Mastectomy; Lymphedema; Breast Cancer
• Interventions: Procedure: OPERA

• Registration Number: NCT06415526
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-03
• Primary Completion: 2024-05-10
• Study Completion: 2024-05-10
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Last Update Submitted: 2024-05-10
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OPERA group	OPERA	Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan