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CompletedNCT05917834Updated Jun 26, 2023

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

An observational study in Breast Cancer and Nipple Sparing Mastectomy, sponsored by Gangnam Severance Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-26.

Sponsored by Gangnam Severance Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
105
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Breast Cancer
  • Nipple Sparing Mastectomy

Keywords

  • NAC sensory
  • Mastectomy
  • NSM
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In context

Lead sponsor

Gangnam Severance Hospital is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with breast cancer undergoing nipple sparing mastectomy

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
105 participants (actual)
Patient registry
No

Groups and cohorts

  • Imframammary

    Imframammary- NSM using imframammary incision

    Biological: Nipple sparing mastecomy with different incision placements

  • Radial/Peri-areolar

    Radial/Peri-areolar- NSM using Radial/Peri-areolar incision

    Biological: Nipple sparing mastecomy with different incision placements

Interventions

  • BiologicalNipple sparing mastecomy with different incision placements

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

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What researchers measure

Primary outcomes

  1. Loss of NAC sensory by pinprick test

    Difference in NAC sensory loss between the patients with two different incisions.

    Time frame: 2-4 years after surgery

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Study locations

1 site
  • GangnamSeverance Hospital
    Seoul, Korea, Republic of
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05917834
Lead sponsor
Gangnam Severance Hospital
Responsible party
Joon Jeong (Professor, Gangnam Severance Hospital) — Principal investigator
First posted
Jun 26, 2023
Start date
Oct 21, 2019
Primary completion
Nov 29, 2021
Completion
Nov 29, 2021
Last update
Jun 26, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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