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Nipple Sparing Mastectomy - Cosmetic Outcomes

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ClinicalTrials.gov Identifier: NCT01002014
Recruitment Status : Active, not recruiting
First Posted : October 27, 2009
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Richard White, Carolinas Healthcare System

Brief Summary:
The purpose of this study is to observe the cosmetic outcomes, patient satisfaction, and complications after skin sparing mastectomy with preservation of the nipple areolar complex.

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Reconstruction Cosmesis Procedure: Nipple Sparing Mastectomy Not Applicable

Detailed Description:
The outcomes will be observed in patients with both known cancer diagnosis and in those with indications for prophylactic mastectomy. The cosmetic appearance and complications will be followed through several post operative visits throughout the duration of the study. This study is conducted in conjunction with the plastic and reconstructive surgeons who will be performing the breast reconstruction procedures. Patient satisfaction will be measured via survey format. In addition, local recurrence rates will be compared to patients undergoing traditional mastectomy.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy
Actual Study Start Date : January 21, 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics Mastectomy

Arm Intervention/treatment
Experimental: Nipple Sparing Mastectomy
Patients who undergo nipple sparing mastectomy with preservation of the nipple areolar complex.
Procedure: Nipple Sparing Mastectomy
Skin sparing mastectomy with preservation of the nipple areolar complex




Primary Outcome Measures :
  1. Cosmetic Appearance [ Time Frame: First Post Operative year ]
  2. Patient Satisfaction [ Time Frame: First Post Operative Year ]
  3. Presence of tumor in nipple areolar complex frozen section [ Time Frame: Duration of Study ]
  4. Presence of tumor in nipple areolar complex permanent histology [ Time Frame: Duration of study ]

Secondary Outcome Measures :
  1. Complications [ Time Frame: First Post Operative year ]
  2. Local Recurrence [ Time Frame: One year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients requiring mastectomy for cancer and/or prophylaxis
  • Age greater than or equal to 18 at time of surgery
  • BMI less than or equal to 35
  • If mastectomy is indicated for removal of breast cancer, tumor is clinically T1 or T2

Exclusion Criteria:

  • Currently smoking
  • Prior radiation to the affected breast
  • Systemic lupus erythematosus
  • Central tumor location and/or tumor within 2 cm of NAC
  • Paget's disease of the nipple
  • Clinical evidence of tumor involvement in the nipple
  • Clinical evidence of axillary nodal tumor involvement
  • Lymphovascular invasion of the tumor on core biopsy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002014


Locations
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: Richard L White, MD Carolinas Healthcare

Publications:

Responsible Party: Richard White, Chief, Division of Surgical Oncology, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01002014     History of Changes
Other Study ID Numbers: LCI NAC-SSM
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

Keywords provided by Richard White, Carolinas Healthcare System:
Breast Cancer
Skin Sparing Mastectomy
Breast Cancer Prophylaxis
Nipple Sparing Mastectomy
Nipple Areolar Complex
Mastectomy
Breast Reconstruction
Local recurrence following nipple sparing mastectomy
Cosmetic outcomes following nipple sparing mastectomy
Complications following nipple sparing mastectomy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases