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

NCT ID: NCT05917834

Last Updated: 2023-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-21

Study Completion Date

2021-11-29

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Nipple Sparing Mastectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Imframammary

Imframammary- NSM using imframammary incision

Nipple sparing mastecomy with different incision placements

Intervention Type BIOLOGICAL

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

Radial/Peri-areolar

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

Nipple sparing mastecomy with different incision placements

Intervention Type BIOLOGICAL

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

Interventions

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Nipple sparing mastecomy with different incision placements

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joon Jeong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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GangnamSeverance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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3-2019-0235

Identifier Type: -

Identifier Source: org_study_id

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