Sensory Recovery of Reconstructed Breast With Breast Reconstructive Options

• Conditions: Breast Cancer

• Registration Number: NCT03535012
• Lead Sponsor: Yonsei University

Brief Summary

Over the past 10 years, there have been substantial improvements in breast reconstruction by plastic surgeons, and much has been achieved in aesthetic restoration after mastectomy. Advances in both microsurgery and implants have allowed for a wider variety of surgical methods, and procedural skills that minimize donor site complications have been developed.

With such satisfactory aesthetic results, interest has recently increased not only in breast reconstruction but also in sensory recovery. Due to the growing expectation of patients, sensory discomfort may decrease overall patient satisfaction with breast reconstruction despite good aesthetic results. Hence, for qualitative improvement of breast reconstruction surgery, efforts must be made to restore sensation in the reconstructed breast. There has been little research on the mechanism of sensory recovery despite its clinical importance. This study aimed to compare the degree of sensory recovery in the reconstructed breast using various reconstruction methods as well as to evaluate the status of neural regeneration with harvesting the tissues when nipple reconstruction is performed.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Status Verified: 2018-05
• Study First Submitted: 2018-05-11
• Study First Submitted QC: 2018-05-11
• Last Update Submitted: 2018-05-23
• Study First Posted: 2018-05-24
• Last Update Posted: 2018-05-25
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Female adults over 20 years of age
• Patients who have undergone or plan to undergo total mastectomy and immediate breast reconstruction after the diagnosis of breast cancer (including carcinoma in situ)
• written consent to study participation

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Exclusion Criteria

• presence of neuropathy that may hinder accurate assessment of sensation
• presence of dermatological condition that may hinder accurate assessment of sensation
• inability to provide written consent
• decided by the research team to be unsuitable for this study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensory recovery in the reconstructed breast according to reconstructive options	18 months (±2 months) after immediate breast reconstruction surgery	Subjects will be followed up with quantitative sensory testing at 18 months (±2 months) after immediate breast reconstruction surgery.

Trial Locations

Locations (1)

Department of Plastic Surgery, Yonsei University School of Medicine, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of