Evaluation of the effectiveness and safety of laparoscopic assisted breast resection with preservation of nipple and areola, combined with chest muscle anterior prosthesis and patch for immediate one-step breast reconstruction and concurrent autologous fat transplantation in a prospective study
This study is a prospective, single center, single arm clinical trial. It is planned to recruit 29 patients with unilateral breast cancer of cT1-2N0M0. Patients who meet the inclusion criteria are planned to undergo laparoscopic assisted NSM+prosthesis combined with patch breast reconstruction and concurrent fat transplantation surgery. Main endpoint of the study: incidence of severe complications after breast reconstruction surgery. Secondary study endpoints: BREAST-Q (Breast Reconstruction Module) score, breast reconstruction success rate, incidence of all complications, physician evaluated breast cosmetic outcomes, occurrence of capsule contractures, nipple areola and breast skin sensation, and tumor safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Laparoscopic assisted mastectomy with preservation of nipple and areola, combined with chest muscle anterior prosthesis and patch, immediate one-step breast reconstruction and simultaneous autologous fat transplantation
Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGIncidence of serious complications after breast reconstruction surgery
All surgical related complications (including hematoma, poor wound healing, skin flap necrosis, infection, incision dehiscence, fat injection related complications, etc.) are classified according to the Clavien Dindo scoring system. The Clavien Dindo grading system is based on the severity of postoperative complications and whether corresponding treatment is needed for the complications. Postoperative complications are classified into grades I-V, and those classified as grade III or above by Clavien Dindo are considered serious complications.
Time frame: One week after surgery, one month after surgery, three months after surgery, six months after surgery, and one year after surgery
BREAST-Q (Breast Reconstruction Module) score
This experiment obtained subject report results from four dimensions of breast satisfaction, psychological health, physical health, and sexual health using the BREAST-Q (Breast Reconstruction Module) scoring system. BREAST-Q scoring was performed at preoperative, 1 month, 3 months, 6 months, and 12-month follow-up. The BREAST-Q score at 12 months after surgery is the main evaluation metric.
Time frame: BREAST-Q scoring was performed at preoperative, postoperative 1-month, 3-month, 6-month, and 12-month follow-up
Success rate of breast reconstruction
Calculation formula:The result of subtracting the number of implant removal cases caused by complications from the total number of breast reconstruction cases received, divided by the total number of reconstruction cases received.Definition of implant removal caused by complications: Refers to the removal of implants during the 12-month follow-up period due to surgical related reasons such as hematoma, serum swelling, skin flap necrosis, nipple areola necrosis, infection, incision dehiscence, implant exposure, capsule contraction, and prosthesis displacement.
Time frame: One year after surgery
All incidence of complications
Complications such as hematoma, poor wound healing, skin flap necrosis, infection, incision dehiscence, and fat injection related complications are classified according to the Clavien Dindo scoring system, including grades I-V, and evaluated and recorded.
Time frame: On the day of surgery, one week after surgery, one month after surgery, three months after surgery, six months after surgery, and one year after surgery
Breast cosmetic effects evaluated by doctors
The cosmetic effect of breast reconstruction is evaluated by professional doctors independent of the surgeon using the ueda scoring criteria based on patient photos.
Time frame: Before surgery,on the day of surgery, one months after surgery,three months after surgery, six months after surgery, and one year after surgery
Occurrence of capsule contraction
The Baker classification method (Spear\&Baker, 1995) was used for evaluation.
Time frame: one months after surgery,three months after surgery, six months after surgery, and one year after surgery
Nipple, areola, and breast skin sensation
The Semmes Weinstein single filament inspection method was used to measure tactile sensation. Semmes Weinstein Monofilament Inspection Method
Time frame: Before surgery, one week after surgery, one months after surgery,three months after surgery, six months after surgery, and one year after surgery
Tumor safety
Disease free survival (DFS) and overall survival (OS). DFS defines the time from surgery to the occurrence of recurrence, metastasis, or last follow-up. OS defines the time from surgery to patient death or last follow-up.
Time frame: five years after surgery
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