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Completed

NCT Number: NCT04866992

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

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.

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Key information

Conditions

Anatomic Stage IA Breast Cancer AJCC v8 Adenocarcinoma Anatomic Stage I 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 Carcinoma In Situ Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Ductal Carcinoma in Situ Neoplasms Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Feasibility of completion of SPrNSM through axillary incision

    Time frame: 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

  2. Complication rate of patients requiring re-operation

    Time frame: Up to 1 year

    Number of patients with bleeding requiring a second surgery after SPrNSM

  3. Complication rate of patients with infection requiring explantation of tissue expander

    Time frame: Up to 1 year

    Number of patients with infection after surgery requiring explantation of tissue expander

  4. Complication rate of patients with mastectomy flap necrosis

    Time frame: Up to 1 year

    number of patients with skin, or nipple-areolar flap necrosis using SKIN flap score

  5. Operative surgery time trends with peri-operative outcomes

    Time frame: Up to 1 year

    Measure total surgery time in relation to other outcomes in each patient

Secondary outcomes

  1. Patient reported outcomes

    Time frame: 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.

  2. Patient reported outcomes

    Time frame: Up to 1 year

    Skin and nipple sensation post operatively with Semmes Weinstein monofilament exam

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Acronym: SPrNSM

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2021
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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