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NCT05917834 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05917834
Other study ID # 3-2019-0235
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 21, 2019
Est. completion date November 29, 2021

Study information
Verified date June 2023
Source Gangnam Severance Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date November 29, 2021
Est. primary completion date November 29, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Nipple sparing mastecomy with different incision placements
Nipple sparing mastectomy was performed using Radial/Peri-areolar incision or imframammary incision

Locations
Country Name City State
Korea, Republic of GangnamSeverance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Loss of NAC sensory by pinprick test Difference in NAC sensory loss between the patients with two different incisions. 2-4 years after surgery
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