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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reconstruction using an implant | 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 | 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. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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This study will be conducted by dividing the subjects into two groups(25 per each arm) according to the method of reconstruction: implant vs. abdominal tissue. It is difficult to determine a sample size that can establish statistical significance based on previous studies. Therefore, the number of targeted subjects was estimated based on the number of patients that can generally be recruited during the study period.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Plastic Surgery, Yonsei University School of Medicine, Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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A sample of 5 mm3 including skin tissue from the flap for reconstruction at the time of immediate breast reconstruction A sample of 5 mm3 including skin tissue at the time of nipple reconstruction (nipple reconstruction will be performed at the time requested by the subject)
| D017437 |
| Skin and Connective Tissue Diseases |