## Protocol Section
### Identification Module
**NCT ID:** NCT06415526

**Brief Title:** OPERA - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction

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

#### Organization Study ID Info
**ID:** 202400581B0
#### Organization
**Class:** OTHER
**Full Name:** Chang Gung Memorial Hospital
### Status Module
#### Completion Date
**Date:** 2024-05-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-05-10

**Type:** ACTUAL

#### Start Date
**Date:** 2024-05-03

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Chang Gung Memorial Hospital

#### Responsible Party

**Investigator Affiliation:** Chang Gung Memorial Hospital

**Investigator Full Name:** Jung-Ju Huang

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Breast Cancer

- Mastectomy; Lymphedema

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 14

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: OPERA

**Label:** OPERA group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- OPERA group

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

**Name:** OPERA

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** The length of incision on anterior rectus sheath

**Measure:** ARS incision

**Time Frame:** Intra-operative

**Description:** The time it took to dissect pedicles with robotic arms

**Measure:** Robotic time

**Time Frame:** Intra-operative

**Description:** The weight of the flap harvested

**Measure:** Flap size

**Time Frame:** Intra-operative

### Eligibility Module

**Eligibility Criteria:** 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)

**Maximum Age:** 80 Years

**Minimum Age:** 20 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Taoyuan

**Country:** Taiwan

**Facility:** Chang Gung Memorial Hospital

**Zip:** 33305

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008206

- Term: Lymphatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M11206

- Name: Lymphedema

- Relevance: HIGH

- As Found: Lymphedema

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008209

- Term: Lymphedema

### Misc Info Module

- Version Holder: 2024-05-31
