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

Completed

• Conditions: Breast Cancer; Nipple Sparing Mastectomy
• Interventions: Biological: Nipple sparing mastecomy with different incision placements

• Registration Number: NCT05917834
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-21
• Primary Completion: 2021-11-29
• Study Completion: 2021-11-29
• Status Verified: 2023-06
• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-15
• Last Update Submitted: 2023-06-15
• Study First Posted: 2023-06-26
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Imframammary	Nipple sparing mastecomy with different incision placements	Imframammary- NSM using imframammary incision
Radial/Peri-areolar	Nipple sparing mastecomy with different incision placements	Radial/Peri-areolar- NSM using Radial/Peri-areolar incision

Primary Outcome Measures

Name	Time	Method
Loss of NAC sensory by pinprick test	2-4 years after surgery	Difference in NAC sensory loss between the patients with two different incisions.

Trial Locations

Locations (1)

GangnamSeverance Hospital; 🇰🇷 Seoul, Korea, Republic of