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

June 15, 2023 updated by: Joon Jeong, Gangnam Severance Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with breast cancer undergoing nipple sparing mastectomy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Imframammary
Imframammary- NSM using imframammary incision
Biological: Nipple sparing mastecomy with different incision placements
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
Biological: Nipple sparing mastecomy with different incision placements
Nipple sparing mastectomy was performed using Radial/Peri-areolar incision or imframammary incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2-4 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2019

Primary Completion (Actual)

November 29, 2021

Study Completion (Actual)

November 29, 2021

Study Registration Dates

First Submitted

June 15, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3-2019-0235

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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