NCT05917834

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

2.1 years

First QC Date

June 15, 2023

Last Update Submit

June 15, 2023

Conditions

Breast CancerNipple Sparing Mastectomy

Keywords

NAC sensoryMastectomyNSM

Outcome Measures

Primary Outcomes (1)

  • Loss of NAC sensory by pinprick test

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

    2-4 years after surgery

Study Arms (2)

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

Nipple sparing mastecomy with different incision placementsBIOLOGICAL

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

ImframammaryRadial/Peri-areolar

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with breast cancer undergoing nipple sparing mastectomy

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 15, 2023

First Posted

June 26, 2023

Study Start

October 21, 2019

Primary Completion

November 29, 2021

Study Completion

November 29, 2021

Last Updated

June 26, 2023

Record last verified: 2023-06

Locations

KR(1)