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

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04866992
Collaborator
(none)
10
1
19.7
0.5

Study Details

Study Description

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 Design

Study Type:
Observational
Actual Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy
Actual Study Start Date :
Feb 1, 2020
Actual Primary Completion Date :
Jul 14, 2021
Actual Study Completion Date :
Sep 24, 2021

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Complication rate of patients requiring re-operation [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 [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 [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 [Up to 1 year]

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

Secondary Outcome Measures

  1. 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.

  2. Patient reported outcomes [Up to 1 year]

    Skin and nipple sensation post operatively with Semmes Weinstein monofilament exam

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UT Southwestern Medical Center Dallas Texas United States 75390

Sponsors and Collaborators

  • University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Deborah Farr, M.D., UT Southwestern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Deborah Farr, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT04866992
Other Study ID Numbers:
  • STU-2019-0522
First Posted:
Apr 30, 2021
Last Update Posted:
Jan 21, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Deborah Farr, Assistant Professor, University of Texas Southwestern Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 21, 2022