Sensory Recovery of Reconstructed Breast With Breast Reconstructive Options

Study Overview
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Brief Summary
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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.

Official Title
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Sensory Recovery of Reconstructed Breast With Breast Reconstructive Options

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Reconstruction using an implant<br>Immediate 2 stage implant based breast reconstruction after mastectomy. All expanders are placed in the subpectoralis muscle using ADM as a sling. After expansion of the tissue expander change to the permanent implant is performed. | |
| Reconstruction using abdominal tissue<br>immediate free DIEP flap breast reconstruction after mastectomy. DIEP(deep inferior epigastric perforator) free flap was prepared and transferred to the breast pocket. Microanastomosis was done under the microscopic magnification. On sitting position, free flap was inset into breast pocket with confirming of satisfactory inflammatory fold. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory recovery in the reconstructed breast according to reconstructive options | Subjects will be followed up with quantitative sensory testing at 3 months (±1 month) after immediate breast reconstruction surgery. | 3 months (±1 month) after immediate breast reconstruction surgery | 
| Sensory recovery in the reconstructed breast according to reconstructive options | Subjects will be followed up with quantitative sensory testing at 6 months (±1 month) after immediate breast reconstruction surgery. | 6 months (±1 month) after immediate breast reconstruction surgery | 
| Sensory recovery in the reconstructed breast according to reconstructive options | Subjects will be followed up with quantitative sensory testing at 12 months (±2 months) after immediate breast reconstruction surgery. | 12 months (±2 months) after immediate breast reconstruction surgery | 
| Sensory recovery in the reconstructed breast according to reconstructive options | Subjects will be followed up with quantitative sensory testing at 18 months (±2 months) after immediate breast reconstruction surgery. | 18 months (±2 months) after immediate breast reconstruction surgery |