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OpenTrials
Completed

NCT Number: NCT05917834

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nipple Sparing Mastectomy Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

GangnamSeverance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females who are older than 18
  • Patients who underwent nipple sparing mastectomy in Gangnam Severance Hospital

Exclusion criteria

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

Treatment and study plan

Nipple sparing mastecomy with different incision placements

Biological

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

Primary outcomes

  1. Loss of NAC sensory by pinprick test

    Time frame: 2-4 years after surgery

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

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 26, 2023
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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