An observational study in Breast Cancer, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-05-25.
Sponsored by Yonsei University · Observational
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.
Yonsei University is the lead sponsor of 1,387 studies on the registry; 231 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 18 months (±2 months) after immediate breast reconstruction surgery
Plan to share: No
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This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Yonsei University