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| Name | Class |
|---|---|
| First Hospital of China Medical University | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
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This study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage IBBR compared with those of two-stage IBBR with TiLoop® Bra.
Studies comparing two-stage implant-based breast reconstruction with immediate one-stage implant-based breast reconstruction have inconsistent results and investigators find that there is a lack of high quality evidence focusing on comparing one-stage and two-stage implant-based breast reconstruction with TiLoop®Bra.
This study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage IBBR compared with those of two-stage IBBR with TiLoop® Bra in breast cancer patients.
The hypothesis is that one step method is not inferior to two step method in implant based breast reconstruction following skin-sparing and/or Nipple-sparing mastectomy using TiLoop® Bra.
The current study is a randomized multicenter, open labeled, prospective, controlled study.
Participants were enrolled at six hospitals in different places of China. All participants will undergo Skin Sparing Mastectomy(SSM)/Nipple Sparing Mastectomy(NSM) with one-stage or two stage IBBR with TiLoop® Bra.
Based on earlier experience, investigators calculated that the surgical complication rate was approximately 30 percent in the one-stage group and 25 percent in the two-stage group. Consider a dropout rate of 5%, a total of 450 patients, with 225 in each group, are needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One step method | Experimental | Immediate implant reconstruction following mastectomy using TiLoop®Bra (one step method) n=225 |
|
| Two step method | Active Comparator | Immediate-delayed implant reconstruction following mastectomy using TiLoop®Bra (two step method) n=225 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate IBBR+TiLoop®Bra | Procedure | Patients will receive immediate implant reconstruction following mastectomy using TiLoop®Bra |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of perioperative complications | The rate of perioperative complication between the two groups | Start of randomization until 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life:EORTC QLQ C30 /+ BR23 questionnaire | EORTC QLQ C30 /+ BR23(EORTC breast cancer-specific quality of life) questionnaire to evaluate quality of life. Participants report the extent to which they have experienced those symptoms or problems during the past week. Each of the symptoms or problems is indicated with four extents, including "not at all" for 1 score,"a little" for 2 score, "quit a bit" for 3 score and "very much" for 4 score. A higher score indicated a worse quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiong Wu, M.D. | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital,Sun Yat-sen University | Guangzhou | Guangdong | 501120 | China | ||
| Guangdong Women and Children Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37216212 | Derived | Chi W, Zhang Q, Li L, Chen M, Xiu B, Yang B, Wu J. Immediate Breast Reconstruction After Neoadjuvant Chemotherapy: Factors Associated With Surgical Selection and Complications. Ann Plast Surg. 2023 Jul 1;91(1):48-54. doi: 10.1097/SAP.0000000000003574. Epub 2023 May 19. |
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| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
All patients will undergo Skin Sparing Mastectomy(SSM)/Nipple Sparing Mastectomy(NSM) with one-stage or two stage IBBR with TiLoop® Bra.
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| Immediate-delayed IBBR+TiLoop®Bra | Procedure | Patients will receive immediate-delayed implant reconstruction following mastectomy using TiLoop®Bra |
|
| 18 months after surgery |
| Patient satisfaction:Breast-Q questionnaire | Breast-Q questionnaire to evaluate patients' satisfaction Using the reconstruction module of BREAST-Q to evaluate patient-reported outcome (PRO) of the surgery.For each subtheme, one or more BREAST-Q scales were developed to examine specific aspects of patient satisfaction. Patient responses to each scale's items are transformed through the Q-Score scoring software to provide a total scale score that ranges from 0 to 100. For all BREAST-Q scales, a higher score means greater satisfaction. | 18 months after surgery |
| Aesthetic score of reconstructed breast | Harris evaluation system to evaluate patients' breast aesthetic after surgery. Harris evaluation system is a 4-staged subjective evaluation method scored as "excellent," "good," "fair," "poor" . | 18 months after surgery |
| Additional surgery | The type of additional surgery following breast reconstruction | 18 months after surgery |
| Angiopathology-related assessment of Tiloop bra | The angiopathology-related assessment in immediate-delayed reconstruction group | 18 months after surgery |
| Guangzhou |
| Guangdong |
| 511400 |
| China |
| Hebei Cancer Hospital | Shijiazhuang | Hebei | 050000 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| The first hospital of China medical university | Shengyang | Liaoning | 110001 | China |
| Liaoning Cancer Hospital & Insitute | Shenyang | Liaoning | 110801 | China |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
| Cancer Hospital/ Institute, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310004 | China |
| Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310006 | China |
| The Second Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | 310009 | China |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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