Surgical and Patient Reported Outcomes in Robotic Mastectomy

Changi General Hospital29 enrolled

Overview

Conventional nipple and/or skin-sparing mastectomy (NSM/SSM) with or without immediate reconstruction is becoming one of the mainstream surgical treatment for breast cancer and risk reducing mastectomy in recent years. While this technique provides satisfactory oncologic and aesthetic outcomes, its disadvantages include skin flap and/or nipple-areolar complex (NAC) necrosis, NAC malposition/distortion as well as visible scar(s) on the breast. In terms of technical aspects, NSM/SSM has its inherent challenges in view of limited incisions and thereby difficulties in dissection. Since 2015, a number of institutions worldwide had adopted a new technique of NSM/SSM using robotic surgical system. Institutional experiences worldwide demonstrated feasibility and safety of this technique coupled with improved patients' satisfactions. To date, there is no center in Singapore or the region offering Robotic NSM/SSM (R-NSM/R-SSM). The authors believe that robotic mastectomy is a feasible and safe technique that can be utilized in our institution and it provides superior aesthetic outcomes with less morbidity and higher patient satisfaction if compared to conventional NSM/SSM. The aim of this study is to conduct a single-arm prospective pilot study to investigate the safety and feasibility as well as learning curve of R-NSM/R-SSM.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women aged 21-70, with invasive breast cancer, ductal carcinoma in situ (DCIS), Breast Cancer (BRCA) gene or other breast cancer genetic mutation carriers or high risk female patients who are otherwise candidates for conventional NSM/SSM will be eligible for the study. All suitable patients will be offered the option of R-NSM/ R-SSM. For patients with breast cancer (invasive or DCIS), selection criteria include but not limited to: 1. Early breast cancer 2. Tumor size less than 5 cm 3. No evidence of lymph node metastases 4. No evidence of skin or chest wall invasion. Exclusion Criteria: 1. Extensive axillary lymph node metastasis (Stage 3B or later) 2. Heavy smokers (\>20 cigarettes a day) 3. High risk patient with severe and poorly controlled co-morbid conditions (include but not limited to diabetes, heart disease, renal failure or liver dysfunction) 4. Poor performance status or high risk for anaesthesia (ASA 3 and above) 5. Inflammatory or Locally Advanced Breast Cancer (with or without chest wall or skin invasion)

Outcomes

Primary Outcomes

Surgical Outcomes - Operative parameters

\- Operative parameters (in terms of docking time/console time and total operative time - defined as time taken from axilla staging procedure, robot docking time, console time, closure and time taken for reconstruction, if applicable

Time frame: Postoperative Day 0-1

Surgical Outcomes - Length of stay (days)

\- Length of stay (days)

Time frame: Postoperative 30 days

Surgical Outcomes- 30-days morbidity/complications

\- 30-days morbidity/complications

Time frame: Postoperative 30 days

Secondary Outcomes

Oncologic outcomes

Short-term oncologic outcomes, such as positivity of margins

Time frame: Postoperative 2 weeks until final histopathology results are available

Learning curve

Learning curve analysis using cumulative sum (CUSUM) method

Time frame: Postoperative up to 2 years throughout study recruitment