Clinical trial NCT04866992: Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy (SPrNSM)
Official title: Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage IB Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Ductal Carcinoma in Situ
Prognostic Stage I Breast Cancer AJCC v8
Prognostic Stage II Breast Cancer AJCC v8
BRCA1 Mutation
BRCA2 Mutation
Keywords: Nipple Sparing Mastectomy
Robot-assisted Nipple Sparing Mastectomy
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult women who undergo robotic nipple sparing mastectomy (rNSM) with reconstruction.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of completion of SPrNSM through axillary incision
timeFrame: Up to 1 year
measure: Complication rate of patients requiring re-operation
timeFrame: Up to 1 year
measure: Complication rate of patients with infection requiring explantation of tissue expander
timeFrame: Up to 1 year
measure: Complication rate of patients with mastectomy flap necrosis
timeFrame: Up to 1 year
measure: Operative surgery time trends with peri-operative outcomes
timeFrame: Up to 1 year
Secondary outcomes:
measure: Patient reported outcomes
timeFrame: Up to 1 year
measure: Patient reported outcomes
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern
name: Deborah Farr, M.D.
role: PRINCIPAL_INVESTIGATOR
References: