Robotic Nipple-Sparing Mastectomy Vs Conventional Open Technique
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|ClinicalTrials.gov Identifier: NCT03440398|
Recruitment Status : Active, not recruiting
First Posted : February 21, 2018
Last Update Posted : January 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Robotic NSM Procedure: Open NSM||Not Applicable|
High proportion of patients with newly diagnosed early-stage breast cancer in Europe and US undergo to mastectomy. The absolute numbers of mastectomy rates in US is still today around 38% and represent one of the most performed operation for cancer reasons. Despite the lack of a natural cavity needed for endoscopic viewing, applications of robotic surgery have recently emerged for superficial organs such as in the fields of thyroidectomy, oropharyngeal surgery, plastic and reconstructive surgery. However, it has never been applied in breast cancer except for a feasibility and safety study conducted at European Institute of Oncology.
The technique was firstly published by Toesca et al. considering the first 3 cases. The same research as continued on breast cancer evaluating feasibility, reproducibility and safety studying 26 consecutive procedures of robotic nipple sparing mastectomy and immediate robotic breast reconstruction (article under peer to peer review at European Journal of Surgical Oncology, EJSO). In these initial cases of robotic nipple sparing mastectomy and immediate breast reconstruction authors found two main advantages such as the robotic optical vision and the minimal invasiveness. The two main limitations noticed in this initial experience were the duration of operating time and the additional costs related to the operation. The limitations of the applicability of robotic surgery to the breast, such as operating time and costs, might be offset by the advantages they observed such as better vision and minimally invasive approach with an anatomically more respectful mastectomy.
This project is a superiority trial comparing robotic nipple sparing mastectomy and immediate breast robotic reconstruction with conventional open technique.
The primary end-point is to evaluate patient satisfaction. Second end-point is to compare post-operative outcome considering complications, post-operative pain, reduction of the average length of stay of patients, long term oncological outcome of the two different surgical techniques.
Patients will be randomized into two treatment arms:
A. Open nipple-sparing mastectomy and immediate breast reconstruction with implant (Open NSM) B. Robotic nipple-sparing mastectomy and immediate robotic breast reconstruction with implant (Robotic NSM) Both arms will undergo to the same pre-surgical staging, intra-operative axillary surgical staging, post-operative multidisciplinary evaluation and adjuvant treatments according to international and internal protocols.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Robotic Nipple-Sparing Mastectomy And Immediate Robotic Breast Reconstruction Vs Conventional Open Technique: A Prospective Randomized Trial Evaluating Patients Satisfaction|
|Actual Study Start Date :||March 10, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Active Comparator: Open NSM
Conventional Nipple Sparing Mastectomy
Procedure: Open NSM
Open nipple-sparing mastectomy and immediate breast reconstruction with implant
Experimental: Robotic NSM
Robotic Nipple-Sparing Mastectomy
Procedure: Robotic NSM
Surgical technique conducted using robot to perform nipple sparing mastectomy and breast reconstruction
- Patient satisfaction [ Time Frame: 1 year ]The BREAST-Q survey is used to detect differences in patient satisfaction among the groups
- Average length of stay of patients [ Time Frame: 1 month ]Reduction of the average length of stay of patients of the two different surgical techniques.
- Post operative complications [ Time Frame: 1 month ]Compare post operative complications (pain, skin or nipple-areola injury or necrosis or infection, hematoma, seroma)
- Cumulative incidence of local recurrence [ Time Frame: 5 years ]Cumulative incidence of local recurrence
- Cumulative incidence of axillary recurrences [ Time Frame: 5 years ]Cumulative incidence of axillary recurrences
- Cumulative incidence of distant recurrences [ Time Frame: 5 years ]Cumulative incidence of distant recurrences
- Disease free survival [ Time Frame: 5 years ]Disease free survival
- Overall survival [ Time Frame: 5 years ]Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440398
|European Institute of Oncology|
|Milan, Italy, 20145|
|Principal Investigator:||Antonio Toesca, MD||European Institute of Oncology|