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NCT Number: NCT06335550

Surgical and Patient Reported Outcomes in Robotic Mastectomy

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Changi General Hospital

Singapore, 529889

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • Early breast cancer
  • Tumor size less than 5 cm
  • No evidence of lymph node metastases
  • No evidence of skin or chest wall invasion.

Exclusion criteria

  • Extensive axillary lymph node metastasis (Stage 3B or later)
  • Heavy smokers (>20 cigarettes a day)
  • High risk patient with severe and poorly controlled co-morbid conditions (include but not limited to diabetes, heart disease, renal failure or liver dysfunction)
  • Poor performance status or high risk for anaesthesia (ASA 3 and above)
  • Inflammatory or Locally Advanced Breast Cancer (with or without chest wall or skin invasion)

Treatment and study plan

Robotic mastectomy

Procedure

Robotic mastectomy with or without reconstruction

Primary outcomes

  1. Surgical Outcomes - Operative parameters

    Time frame: Postoperative Day 0-1

    • 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

  2. Surgical Outcomes - Length of stay (days)

    Time frame: Postoperative 30 days

    • Length of stay (days)

  3. Surgical Outcomes- 30-days morbidity/complications

    Time frame: Postoperative 30 days

    • 30-days morbidity/complications

Secondary outcomes

  1. Oncologic outcomes

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

    Short-term oncologic outcomes, such as positivity of margins

  2. Learning curve

    Time frame: Postoperative up to 2 years throughout study recruitment

    Learning curve analysis using cumulative sum (CUSUM) method

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 28, 2024
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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