Robotic vs. Open Mastectomy for Breast Cancer

(SP NSM Trial)

Recruiting at 16 trial locations

Overseen By Brittanny Boyer

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Intuitive Surgical

Disqualifiers: Metastatic cancer, Smoking, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial compares the safety and effectiveness of a new robotic surgery tool, the da Vinci SP Surgical System, to traditional open surgery for patients undergoing breast surgery that spares the nipple. The robotic system aims to improve precision and recovery. The da Vinci SP Surgical System is one of the latest versions of robotic surgery systems, designed for minimally invasive procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment da Vinci SP Surgical System for breast cancer?

The da Vinci SP Surgical System, used for robotic nipple-sparing mastectomy, has shown to be feasible and safe with promising features for breast reconstruction. Studies indicate it has a lower rate of overall complications compared to conventional methods, with good cosmetic results and high patient satisfaction. ^{1 2 3 4 5}

Is the da Vinci SP surgical system generally safe for use in humans?

The da Vinci SP surgical system has been used in various surgeries, including colorectal and urological procedures, with studies focusing on its safety and performance. Initial results suggest it is generally safe, but these findings are based on early experiences and small sample sizes. ^{6 7 8 9 10}

How does the robotic nipple-sparing mastectomy treatment differ from other treatments for breast cancer?

The robotic nipple-sparing mastectomy (R-NSM) using the da Vinci SP Surgical System is unique because it allows for smaller, less visible incisions and offers a minimally invasive approach, which can lead to better cosmetic results and lower complication rates compared to conventional open nipple-sparing mastectomy (C-NSM). This robotic approach also provides enhanced precision and control during surgery, potentially improving patient satisfaction. ^{1 2 3 4 11}

Research Team

Madhu Gorrepati

Principal Investigator

Intuitive

Eligibility Criteria

This trial is for women over 21 with a breast cup size of C or smaller, BMI under 30, diagnosed with early stage breast cancer and suitable for Nipple Sparing Mastectomy (NSM) with immediate reconstruction. It's not for those who've had previous breast surgery, are pregnant/breastfeeding, have bleeding/clotting disorders, prior chest radiation treatment, smoke currently or can't undergo general anesthesia.

Inclusion Criteria

My breast sagging is mild to moderate.

I have been diagnosed with early stage breast cancer.

You have a cup size smaller than C.

Exclusion Criteria

I cannot have general anesthesia or surgery due to health risks.

I have had breast surgery before.

Pregnant or suspected to be pregnant, or actively breastfeeding

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either robotic NSM with the da Vinci SP system or conventional open NSM procedures

During procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse event rates and surgical margin rates

Up to 42 days post-operatively

Long-term Follow-up

Participants are monitored for oncological outcomes, including disease-free survival, overall survival, and cancer recurrence

Up to 5 years

Treatment Details

Interventions

• da Vinci SP Surgical System (Robotic Surgery)
• Open NSM (Procedure)

Trial Overview The study compares the safety and effectiveness of two types of mastectomy procedures: one using the da Vinci SP Surgical System (Robotic NSM) and the other traditional open surgery (Open NSM). The goal is to see which method might be better for patients undergoing nipple sparing mastectomies.

Participant Groups

Group I: Robotic NSM with da Vinci SP Experimental Treatment 1 Intervention

Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures

Group II: Open NSM Active Control 1 Intervention

Subjects randomized to this arm will undergo conventional open NSM procedures

Who Is Running the Clinical Trial?

Intuitive Surgical

Lead Sponsor

Trials

80

Recruited

49,600+

Gary Guthart

Intuitive Surgical

Chief Executive Officer since 2010

PhD in Engineering, California Institute of Technology

Henry Charlton

Intuitive Surgical

Chief Medical Officer since 2023

MD from an unspecified institution

Findings from Research

Robot-assisted nipple-sparing mastectomy with immediate reconstruction using the da Vinci SP Surgical System was performed on two patients without any major complications, indicating a high level of safety for this surgical approach.

The procedure demonstrated feasibility and advantages such as a simple docking process and advanced instrument functionality, suggesting potential for broader application in breast reconstruction, although further studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-port robot-assisted prosthetic breast reconstruction with the da Vinci SP Surgical System: first clinical report. Joo, OY., Song, SY., Park, HS., et al.[2021]

Robotic nipple sparing mastectomy (R-NSM) demonstrated higher patient satisfaction and better aesthetic outcomes compared to conventional nipple sparing mastectomy (C-NSM), with 92% of R-NSM patients reporting excellent satisfaction versus 75.6% in the C-NSM group.

Both R-NSM and C-NSM had similar risks for nipple areolar complex necrosis and overall complications, but R-NSM involved longer surgery times and higher medical costs, averaging $10,877 compared to $5,702 for C-NSM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic versus conventional nipple sparing mastectomy and immediate gel implant breast reconstruction in the management of breast cancer- A case control comparison study with analysis of clinical outcome, medical cost, and patient-reported cosmetic results. Lai, HW., Chen, ST., Mok, CW., et al.[2020]

Nipple-sparing mastectomy (NSM) using the da Vinci Xi robotic surgical system offers a minimally invasive approach that can improve cosmetic outcomes by hiding the incision behind the axillary line.

This technique allows for the complete removal of breast tissue while being compatible with immediate breast reconstruction, addressing both cancer treatment and patient aesthetic concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic da Vinci Xi-assisted nipple-sparing mastectomy: First clinical report. Sarfati, B., Honart, JF., Leymarie, N., et al.[2022]

Robotic nipple-sparing mastectomy (R-NSM) shows a lower overall complication rate compared to conventional nipple-sparing mastectomy (C-NSM), with a relative risk of 0.68 based on a meta-analysis of six studies involving 63 to 311 mastectomies.

Despite the benefits, R-NSM had a longer operative time and variability in results, indicating that more research is needed to fully understand its effectiveness and oncologic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of robotic nipple-sparing mastectomy versus conventional nipple-sparing mastectomy in women with breast cancer: a systematic review and meta-analysis. De la Cruz-Ku, G., Chambergo-Michilot, D., Perez, A., et al.[2023]

Single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) shows comparable oncologic safety to conventional open mastectomy (C-OM) in early-stage breast cancer, with similar local recurrence rates (1.4% for SIE-NSM vs. 0.9% for C-OM).

Patients undergoing SIE-NSM reported significantly higher satisfaction in breast appearance, psychosocial health, and upper extremity function, along with a lower incidence of complications like subcutaneous effusion (0% in SIE-NSM vs. 10.7% in C-OM).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-port insufflation endoscopic nipple-sparing mastectomy in early breast cancer: a retrospective cohort study. Liu, WH., Wu, SS., Tian, YM., et al.[2023]

The da Vinci SP® surgical system was evaluated in a study involving 50 patients undergoing various colorectal procedures, demonstrating significant reductions in operative time as experience with the system increased, indicating improved efficiency.

The study found that the dVSP system is safe for colorectal surgery, with only six mild adverse events reported and no local recurrences, suggesting it is a promising option for oncological procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-incision robotic colorectal surgery with the da Vinci SP® surgical system: initial results of 50 cases. Kim, HS., Oh, BY., Cheong, C., et al.[2023]

The first successful single-port robotic right colectomy in the USA was performed using the da Vinci SP robot, demonstrating its feasibility and safety with no intraoperative complications and minimal blood loss (100 mL).

The patient had a smooth recovery, tolerating a low-residue diet by postoperative day 1 and being discharged by day 3, indicating that the SP robotic approach may enhance recovery times in colorectal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

rSILS: initial clinical experience with single-port robotic (SPr) right colectomy. Marks, JH., Kunkel, E., Salem, J., et al.[2021]

The study evaluated the safety and feasibility of the da Vinci single-port robotic system for rectal resection in 5 patients with mid or low rectal cancer, showing promising results with all patients achieving tumor-free resection margins.

The median operation time was 195 minutes, and while one patient had an anastomosis-related complication, the overall outcomes suggest that single-port robotic surgery is a viable option that warrants further investigation against traditional multiport methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An initial experience with a novel technique of single-port robotic resection for rectal cancer. Kim, HJ., Choi, GS., Song, SH., et al.[2021]

The da Vinci single-port robotic system is the latest technology approved for urological procedures, offering new capabilities for surgeons.

The article discusses common challenges faced during its use at the University of Illinois at Chicago and provides practical solutions to enhance its effectiveness in surgical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Port Robotic Surgery: General Principles and Troubleshooting. Lai, A., Chen, GL., di Meo, NA., et al.[2022]

The da Vinci Single-Port (SP) platform is a new robotic surgical system that allows for major urological operations to be performed through a single incision, demonstrating technical feasibility in initial clinical experiences from December 2018 to April 2019.

While the SP platform shows promise for minimally invasive surgery, further multi-center studies and randomized trials are necessary to fully understand its role and compare its outcomes to traditional multi-port robotic systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-port robotic surgery: the next generation of minimally invasive urology. Dobbs, RW., Halgrimson, WR., Talamini, S., et al.[2021]

This pilot study aims to evaluate the safety and feasibility of minimally invasive robot-assisted nipple-sparing mastectomy (RNSM) in up to 12 patients, focusing on the successful removal of breast tissue while preserving the nipple-areolar complex.

The study will assess postoperative complications and recovery of breast and nipple sensation, providing valuable insights into the benefits and challenges of RNSM for both patients and surgeons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM). Park, KU., Lee, S., Sarna, A., et al.[2022]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Single-port robot-assisted prosthetic breast reconstruction with the da Vinci SP Surgical System: first clinical report. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Robotic versus conventional nipple sparing mastectomy and immediate gel implant breast reconstruction in the management of breast cancer- A case control comparison study with analysis of clinical outcome, medical cost, and patient-reported cosmetic results. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Robotic da Vinci Xi-assisted nipple-sparing mastectomy: First clinical report. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Outcomes of robotic nipple-sparing mastectomy versus conventional nipple-sparing mastectomy in women with breast cancer: a systematic review and meta-analysis. [2023]

5. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Single-port insufflation endoscopic nipple-sparing mastectomy in early breast cancer: a retrospective cohort study. [2023]

6. Italy pubmed.ncbi.nlm.nih.gov

Single-incision robotic colorectal surgery with the da Vinci SP® surgical system: initial results of 50 cases. [2023]

7. Italy pubmed.ncbi.nlm.nih.gov

rSILS: initial clinical experience with single-port robotic (SPr) right colectomy. [2021]

8. Italy pubmed.ncbi.nlm.nih.gov

An initial experience with a novel technique of single-port robotic resection for rectal cancer. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Single-Port Robotic Surgery: General Principles and Troubleshooting. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Single-port robotic surgery: the next generation of minimally invasive urology. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM). [2022]