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

Anatomic Stage II Breast Cancer AJCC v8 Clinical Trial

— SPrNSM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04866992
• Other study ID #: STU-2019-0522
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: September 24, 2021

Study information

• Verified date: January 2022
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 24, 2021
• Est. primary completion date: July 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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
• BRCA1 Mutation
• BRCA2 Mutation
• Breast Neoplasms
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma in Situ
• Prognostic Stage I Breast Cancer AJCC v8
• Prognostic Stage II Breast Cancer AJCC v8

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Complication rate of patients requiring re-operation	Number of patients with bleeding requiring a second surgery after SPrNSM	Up to 1 year
Primary	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
Primary	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
Primary	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	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
Secondary	Patient reported outcomes	Skin and nipple sensation post operatively with Semmes Weinstein monofilament exam	Up to 1 year