Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy (SPrNSM) (SPrNSM)

Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy

This is a prospective registry trial to determine the outcomes of single port robot-assisted nipple sparing mastectomy (SPrNSM) utilitzing the SP da Vinci surgical system.

Study Overview

• Status: Completed
• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; BRCA1 Mutation; BRCA2 Mutation; Ductal Carcinoma in Situ

Detailed Description

Robotic assisted nipple sparing mastectomies with multi-port robots, like the Da Vinci Xi, have been described previously but pose significant hurdles due to the small area like the breast. The Single-Port da Vinci SP (Intuitive Surgical), which was designed for application to small cavity surgery, may be more appropriately suited for this procedure. This is a prospective registry trial to study the outcomes of performing a single-port robot-assisted nipple sparing mastectomy.

Subjects who undergo rNSM and bilateral breast reconstruction of the affected breast via single site small hidden axillary scar technique will be offered participation in the prospective registry trial at their pre-operative visit in the UT Southwestern Breast Clinic. The patient will then be seen at their regularly scheduled clinic appointments at 2 weeks, 1 month, 6 months, and 1 year post operatively at both Breast and Plastics and Reconstructive Surgery (PRS) departments. Outcomes will be tracked in a prospectively kept electronic registry.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Adult women who undergo robotic nipple sparing mastectomy (rNSM) with reconstruction.

Description

Inclusion Criteria:

1. Subjects age >= 18 years who undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW

Exclusion Criteria:

1. Subjects who are <18 years of age
2. Subjects who do not undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of completion of SPrNSM through axillary incision	Measure number of patients who completed surgery with en bloc removal of the breast through axillary incision v. conversion to open incision	Up to 1 year
Complication rate of patients requiring re-operation	Number of patients with bleeding requiring a second surgery after SPrNSM	Up to 1 year
Complication rate of patients with infection requiring explantation of tissue expander	Number of patients with infection after surgery requiring explantation of tissue expander	Up to 1 year
Complication rate of patients with mastectomy flap necrosis	number of patients with skin, or nipple-areolar flap necrosis using SKIN flap score	Up to 1 year
Operative surgery time trends with peri-operative outcomes	Measure total surgery time in relation to other outcomes in each patient	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcomes	Patient satisfaction is measured using BREAST-Q. Possible scores range from 1-10 Likert scale, with higher scores indicating better/ worse outcome.	Up to 1 year
Patient reported outcomes	Skin and nipple sensation post operatively with Semmes Weinstein monofilament exam	Up to 1 year

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Deborah Farr, M.D., UT Southwestern

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): July 14, 2021
• Study Completion (Actual): September 24, 2021

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Nipple Sparing Mastectomy; Robot-assisted Nipple Sparing Mastectomy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Carcinoma in Situ; Breast Neoplasms; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID Numbers: STU-2019-0522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study share data of individual participants.