Surgical and Patient Reported Outcomes in Robotic Mastectomy

NCT06335550 | Completed

• 1 other identifier: 2021/2680
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Minimally invasive breast surgery; endoscopic breast surgery; robotic breast surgery

Outcome Measures

Primary Outcomes (3)

• 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

• Surgical Outcomes - Length of stay (days)

  \- Length of stay (days)

  Postoperative 30 days

• Surgical Outcomes- 30-days morbidity/complications

  \- 30-days morbidity/complications

  Postoperative 30 days

Secondary Outcomes (2)

• Oncologic outcomes

  Postoperative 2 weeks until final histopathology results are available

• Learning curve

  Postoperative up to 2 years throughout study recruitment

Study Arms (1)

Robotic mastectomy

OTHER

All consecutive cases of robotic mastectomy over the study duration

Procedure: Robotic mastectomy

Interventions

Robotic mastectomy PROCEDURE

Robotic mastectomy with or without reconstruction

Robotic mastectomy

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Chi Wei Mok

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Clinical Assistant Professor

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 28, 2024
• Study Start: November 24, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 1, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

SG (1)