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Comparison of Nipple-areolar Complex Sensation According to Incision Types in Nipple-sparing Mastectomy

Comparison of Nipple-areolar Complex Sensation According to Incision Types in Nipple-sparing Mastectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05917834
Enrollment
105
Registered
2023-06-26
Start date
2019-10-21
Completion date
2021-11-29
Last updated
2023-06-26

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

Conditions

Breast Cancer, Nipple Sparing Mastectomy

Keywords

NAC sensory, Mastectomy, NSM

Brief summary

This study aims to assess nipple areolar complex sensation after nipple sparing mastectomy and compare the results according to different incisional approaches; specifically, inframammary fold (IMF) versus peri-areolar/radial. One-hundred-and-five post NSM patients from Oct 2019 to Nov 2021 have been recruited prospectively and evaluated for NAC sensory. A total of 97 patients (IMF 65 and peri-areolar/radial 32) were included in the analyses for comparison during follow up from 24 to 48 months after surgery. It was hypothesized that patients with IMF would have better outcomes for NAC senroy.

Interventions

BIOLOGICALNipple sparing mastecomy with different incision placements

Nipple sparing mastectomy was performed using Radial/Peri-areolar incision or imframammary incision

Sponsors

Gangnam Severance Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Females who are older than 18 2. Patients who underwent nipple sparing mastectomy in Gangnam Severance Hospital

Exclusion criteria

1. Loss or excision of NAC due to post-surgical necrosis 2. Diagnosis of other conditions that may interfere with cutaneous sensation

Design outcomes

Primary

MeasureTime frameDescription
Loss of NAC sensory by pinprick test2-4 years after surgeryDifference in NAC sensory loss between the patients with two different incisions.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026