Surgical and Patient Reported Outcomes in Robotic Mastectomy

NCT ID: NCT06335550

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-24
• Study Completion Date: 2024-03-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic mastectomy

All consecutive cases of robotic mastectomy over the study duration

Group Type: OTHER

Robotic mastectomy

Intervention Type: PROCEDURE

Robotic mastectomy with or without reconstruction

Interventions

Robotic mastectomy

Robotic mastectomy with or without reconstruction

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Changi General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mok Chi Wei

Principal Investigator; Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chi Wei Mok

Role: PRINCIPAL_INVESTIGATOR

Changi General Hospital

Locations

Changi General Hospital

Singapore, , Singapore

Countries

Singapore

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2021/2680

Identifier Type: -

Identifier Source: org_study_id