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

• Sponsor: Gangnam Severance Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05917834
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Actual Duration (Months): 25.3
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Nipple Sparing Mastectomy	Biological: Nipple sparing mastecomy with different incision placements

Study Design

• Study Type: Observational
• Actual Enrollment: 105 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Comparison of Nipple-areolar Complex Sensation According to Incision Types in Nipple-sparing Mastectomy
• Actual Study Start Date: Oct 21, 2019
• Actual Primary Completion Date: Nov 29, 2021
• Actual Study Completion Date: Nov 29, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Loss of NAC sensory by pinprick test [2-4 years after surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GangnamSeverance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joon Jeong, Professor, Gangnam Severance Hospital
• ClinicalTrials.gov Identifier: NCT05917834
• Other Study ID Numbers: 3-2019-0235
• First Posted: Jun 26, 2023
• Last Update Posted: Jun 26, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Joon Jeong, Professor, Gangnam Severance Hospital: NAC sensory; Mastectomy; NSM

Study Results

No Results Posted as of Jun 26, 2023