Surgical and Patient Reported Outcomes in Robotic Mastectomy

Breast Cancer Clinical Trial

Official title:

Pilot Robotic Mastectomy in Singapore (PRoMiSing I) Study: First Safety and Feasibility Prospective Cohort Study in South East Asia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06335550
• Other study ID #: 2021/2680
• Status: Completed
• Phase: N/A
• Start date: November 24, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Robotic mastectomy
Robotic mastectomy with or without reconstruction

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative Day 0-1
Primary	Surgical Outcomes - Length of stay (days)	- Length of stay (days)	Postoperative 30 days
Primary	Surgical Outcomes- 30-days morbidity/complications	- 30-days morbidity/complications	Postoperative 30 days
Secondary	Oncologic outcomes	Short-term oncologic outcomes, such as positivity of margins	Postoperative 2 weeks until final histopathology results are available
Secondary	Learning curve	Learning curve analysis using cumulative sum (CUSUM) method	Postoperative up to 2 years throughout study recruitment