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

NCT04866992 | Completed DMC

• 1 other identifier: STU-2019-0522
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• Feasibility of completion of SPrNSM through axillary incision

  Measure number of patients who completed surgery with en bloc removal of the breast through axillary incision v. conversion to open incision

  Up to 1 year

• Complication rate of patients requiring re-operation

  Number of patients with bleeding requiring a second surgery after SPrNSM

  Up to 1 year

• Complication rate of patients with infection requiring explantation of tissue expander

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

  Up to 1 year

• Complication rate of patients with mastectomy flap necrosis

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

  Up to 1 year

• Operative surgery time trends with peri-operative outcomes

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

  Up to 1 year

Secondary Outcomes (2)

• Patient reported outcomes

  Up to 1 year

• Patient reported outcomes

  Up to 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult women who undergo robotic nipple sparing mastectomy (rNSM) with reconstruction.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Deborah Farr, M.D.

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 30, 2021
• Study Start: February 1, 2020
• Primary Completion: July 14, 2021
• Study Completion: September 24, 2021
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)