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

Completed

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

• Registration Number: NCT04866992
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-30
• Primary Completion: 2021-07-14
• Study Completion: 2021-09-24
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient reported outcomes	Up to 1 year	Skin and nipple sensation post operatively with Semmes Weinstein monofilament exam

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States