Robotic vs. Open Mastectomy for Breast Cancer
(SP NSM Trial)
Recruiting in Palo Alto (17 mi)
+16 other locations
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.
12345Is 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.
678910How 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.
123411Eligibility 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.
+3 more
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
+4 more
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Robotic NSM with da Vinci SPExperimental Treatment1 Intervention
Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures
Group II: Open NSMActive Control1 Intervention
Subjects randomized to this arm will undergo conventional open NSM procedures
da Vinci SP Surgical System is already approved in United States for the following indications:
🇺🇸 Approved in United States as da Vinci SP Surgical System for:
- Urological procedures including radical prostatectomy, pyeloplasty, nephrectomy, partial nephrectomy
- Simple prostatectomy for benign prostatic hyperplasia (BPH) or enlarged prostate
- Transvesical approach to simple and radical prostatectomy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington University, St. LouisSt. Louis, MO
Endeavor HealthEvanston, IL
Northwell HealthLake Success, NY
Ascension St. Columbia Mary'sMilwaukee, WI
More Trial Locations
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Who Is Running the Clinical Trial?
Intuitive SurgicalLead Sponsor
References
Single-port robot-assisted prosthetic breast reconstruction with the da Vinci SP Surgical System: first clinical report. [2021]Robot-assisted nipple-sparing mastectomy with immediate reconstruction is currently performed in an attempt to seek smaller and indistinct incisions. Robotic surgery system has been evolving under the concept of minimal invasive technique which is a recent trend in surgery. One of the latest version is the da Vinci SP Surgical System (Intuitive Surgical). In this report, we will share our experiences. Two patients underwent robot-assisted nipple-sparing mastectomy, each followed by immediate robot-assisted expander insertion and prepectoral direct-to-implant breast reconstruction, respectively. There was no open conversion or major postoperative complication. One patient experienced mild infection, which was resolved by intravenous antibiotic treatment. Simple docking process, multi-joint instruments, and third-arm functionality are among the new surgical system's advantages. The present cases suggest that robot-assisted nipple-sparing mastectomy with immediate reconstruction using the da Vinci SP Surgical System is feasible and safe. The promising features and potential application of da Vinci SP in breast reconstruction need further study.
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]Robotic nipple sparing mastectomy (R-NSM), which uses the da Vinci surgical platform, could perform NSM and immediate breast reconstruction through a small and inconspicuous extra-mammary axillary or lateral chest incision. R-NSM was reported with extremely low nipple areolar complex (NAC) necrosis rate, good cosmetic results, and high patient satisfaction. However, there was little evidence available comparing the effectiveness and safety of R-NSM and conventional NSM (C-NSM) in the management of breast cancer.
Robotic da Vinci Xi-assisted nipple-sparing mastectomy: First clinical report. [2022]Nipple-sparing mastectomy (NSM) is increasingly popular for the treatment of selected breast cancers and prophylactic mastectomy. Surgical scarring and esthetic outcomes are important patient-related cosmetic considerations. Today, the concept of minimally invasive surgery has become popular, especially using robotic surgery. The authors report the first case of NSM using the latest version of the da Vinci Xi surgical system (Xi). The final incision used to remove the entire mammary gland was located behind the axillary line. In this position, hidden by the arm of the patient, the incision was not visible and was compatible with immediate breast reconstruction.
Outcomes of robotic nipple-sparing mastectomy versus conventional nipple-sparing mastectomy in women with breast cancer: a systematic review and meta-analysis. [2023]The promising results of the robotic approach for multiple cancer operations has led to interest in the potential of robotic nipple-sparing mastectomy (R-NSM); however, further studies are required to compare the benefits and complications of this approach with those of conventional open nipple-sparing mastectomy (C-NSM). We performed a meta-analysis to compare surgical complications of R-NSM versus C-NSM. We performed a review of literature through June 2022 in PubMed, Scopus, and EMBASE. We included randomized controlled trials (RCTs), cohorts, case-control studies, and case series with > 50 patients comparing the two techniques. Separate meta-analyses were conducted according to study design. From 80 publications, we identified six studies. The sample size ranged from 63 to 311 mastectomies from 63 to 275 patients. The tumor size and disease stage were similar between groups. The positive margin rate was 0-4.6% in the R-NSM arm and 0-2.9% in the C-NSM arm. Four studies reported early recurrence data, which were similar between groups (R-NSM: 0%, C-NSM: 0-8%). The R-NSM group had a lower rate of overall complications compared to the C-NSM group in cohorts/RCTs (RR = 0.68, 95%CI 0.49-0.96). In case-control studies, rate of necrosis was lower with R-NSM. Operative time was significantly longer in the R-NSM group in cohort/RCTs. In early experience with R-NSM, R-NSM had a lower overall complication rate compared to C-NSM in cohorts/RCTs. While these data are promising, our results show variability and heterogeneity limiting definitive conclusions. Additional trials are needed to guide the role of R-NSM and its oncologic outcomes.
Single-port insufflation endoscopic nipple-sparing mastectomy in early breast cancer: a retrospective cohort study. [2023]Breast cancer is the most common malignancy in female patients. In recent years, more and more studies have focused on how to improve the appearance and the quality of life for patients. This study aimed to compare the oncologic safety, aesthetic results, and upper extremity function between single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) and conventional open mastectomy (C-OM) in early-stage breast cancer treatment.
Single-incision robotic colorectal surgery with the da Vinci SP® surgical system: initial results of 50 cases. [2023]The da Vinci SP® (dVSP) surgical system (Intuitive Surgical, Sunnyvale, CA, USA), a robotic platform designed for single-incision surgery, overcame the need for multiple ports in traditional robotic surgery and issues including triangulation and retraction in single-incision laparoscopic surgery. However, previous studies only included case reports or series with small sample sizes. The aim of this study was to assess the safety and performance of the dVSP surgical system and its instruments and accessories for colorectal procedures.
rSILS: initial clinical experience with single-port robotic (SPr) right colectomy. [2021]The da Vinci Single-Port (SP) robot is a novel platform designed to facilitate single-incision robotic surgery (rSILS). The objective of this study was to describe our initial experience using this platform for SP robotic (SPr) right colectomy.
An initial experience with a novel technique of single-port robotic resection for rectal cancer. [2021]The da Vinci single-port (SP) system is designed to facilitate single-incision robotic surgery in a narrow space. We developed a new procedure of rectal resection using this system. The aim of the present study was to evaluate the technical feasibility and safety of SP robotic rectal resection for rectal cancer patients based on our initial experience.
Single-Port Robotic Surgery: General Principles and Troubleshooting. [2022]The da Vinci single-port (SP) system (Intuitive Surgical, Sunnyvale, CA) is the newest robotic platform released and approved for use in the urologist's armimentarium. This article (and complementary video) aims to summarize the most common problems that have been encountered at the University of Illinois at Chicago when using the SP system. Moreover, solutions to these issues will be presented.
Single-port robotic surgery: the next generation of minimally invasive urology. [2021]The da Vinci Single-Port (SP) platform (Intuitive Surgical Inc, Sunnyvale CA) is a recently approved robotic surgical platform which features several novel modifications from previously available single trocar models including a flexible camera, articulating instruments, and navigator guidance for real-time monitoring of instrument position. We sought to describe our clinical experience with this device as well as to review the current literature related to the use of the SP platform.
Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM). [2022]Nipple-sparing mastectomy (NSM) can be performed for the treatment of breast cancer and risk reduction, but total mammary glandular excision in NSM can be technically challenging. Minimally invasive robot-assisted NSM (RNSM) has the potential to improve the ergonomic challenges of open NSM. Recent studies in RNSM demonstrate the feasibility and safety of the procedure, but this technique is still novel in the USA.