NCT05917834|Completed
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Sponsor study identifier
observational
105
1 country
1
Study Start
October 21, 2019
Actual (reported)Primary Completion
November 29, 2021
Actual (reported)Study Completion
November 29, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 29, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2019
Actual (reported)November 29, 2021
Actual (reported)November 29, 2021
Actual (reported)June 15, 2023
Actual (reported)June 26, 2023
Actual (reported)Loss of NAC sensory by pinprick test
Difference in NAC sensory loss between the patients with two different incisions.
2-4 years after surgery
Imframammary- NSM using imframammary incision
Radial/Peri-areolar- NSM using Radial/Peri-areolar incision
Nipple sparing mastectomy was performed using Radial/Peri-areolar incision or imframammary incision
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with breast cancer undergoing nipple sparing mastectomy
GangnamSeverance Hospital
Seoul, South Korea
105 participants (actual enrollment reported by the registry).
First Submitted
June 15, 2023
First Posted
June 26, 2023
Study Start
October 21, 2019
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
November 29, 2021
Actual (reported)Study Completion
November 29, 2021
Actual (reported)Last Updated
June 26, 2023
Record last verified: 2023-06
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Source: ClinicalTrials.gov.
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