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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04866992

Acronym

SPrNSM

Enrollment

Registered

2021-04-30

Start date

2020-02-01

Completion date

2021-09-24

Last updated

2022-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, BRCA1 Mutation, BRCA2 Mutation, Ductal Carcinoma in Situ, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8

Keywords

Nipple Sparing Mastectomy, Robot-assisted Nipple Sparing Mastectomy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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
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
Operative surgery time trends with peri-operative outcomes	Up to 1 year	Measure total surgery time in relation to other outcomes in each patient

Secondary

Measure	Time frame	Description
Patient reported outcomes	Up to 1 year	Patient satisfaction is measured using BREAST-Q. Possible scores range from 1-10 Likert scale, with higher scores indicating better/ worse outcome.

Countries

United States

Outcome results