Clinical trial NCT06335550: Surgical and Patient Reported Outcomes in Robotic Mastectomy
Official title: Pilot Robotic Mastectomy in Singapore (PRoMiSing I) Study: First Safety and Feasibility Prospective Cohort Study in South East Asia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Minimally invasive breast surgery
endoscopic breast surgery
robotic breast surgery
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 29
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Surgical Outcomes - Operative parameters
timeFrame: Postoperative Day 0-1
measure: Surgical Outcomes - Length of stay (days)
timeFrame: Postoperative 30 days
measure: Surgical Outcomes- 30-days morbidity/complications
timeFrame: Postoperative 30 days
Secondary outcomes:
measure: Oncologic outcomes
timeFrame: Postoperative 2 weeks until final histopathology results are available
measure: Learning curve
timeFrame: Postoperative up to 2 years throughout study recruitment
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Chi Wei Mok
role: PRINCIPAL_INVESTIGATOR
References: