- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05917834
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
-
-
-
Seoul, Korea, Republic of
- GangnamSeverance Hospital
-
-
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:
- Females who are older than 18
- Patients who underwent nipple sparing mastectomy in Gangnam Severance Hospital
Exclusion Criteria:
- Loss or excision of NAC due to post-surgical necrosis
- 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
|
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
|
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
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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