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This clinical trial aims to determine whether conventional surgery or endoscopic surgery results in better recovery of breast skin sensation in women with early-stage breast cancer undergoing nipple-sparing mastectomy with prepectoral implant reconstruction. Furthermore, the study will compare the safety, aesthetic outcomes, and quality of life associated with the two surgical approaches. The study seeks to address the following primary research questions:
Does conventional surgery lead to superior recovery of breast skin sensation at 6 months postoperatively compared with endoscopic surgery?
What are the differences between the two surgical approaches in terms of complication rates, aesthetic outcomes, and patient-reported quality of life?
Researchers will compare conventional nipple-sparing mastectomy with endoscopic nipple-sparing mastectomy to determine which procedure better preserves postoperative breast sensation.
Participants will:
Be randomly assigned to undergo either conventional or endoscopic surgery.
Have breast skin sensation measured preoperatively and at multiple postoperative follow-up visits using a standardized assessment tool.
Complete validated questionnaires regarding breast satisfaction and quality of life preoperatively and during multiple follow-up visits.
Attend scheduled follow-up visits to monitor for complications and to evaluate the long-term appearance and health of the reconstructed breast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional nipple-sparing mastectomy group | Experimental |
| |
| Endoscopic nipple-sparing mastectomy group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional nipple-sparing mastectomy combined with prepectoral implant reconstruction | Procedure | This procedure is a traditional surgical approach involving a skin incision made on the breast surface. Under direct visualization, the breast glandular tissue is excised while preserving the nipple-areola complex, followed by a reconstructive surgery with implant placement in the prepectoral plane. |
| Measure | Description | Time Frame |
|---|---|---|
| Average breast sensory thresholds at 6 months post breast reconstruction as measured by Semmes-Weinstein Monofilaments | Differences in the mean skin sensory thresholds (measured by Semmes-Weinstein monofilaments across nine breast regions) between the conventional and endoscopic surgery groups were observed at 6 months after breast reconstruction. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with postoperative complications as assessed by Clavien-Dindo Classification System within 1 year after surgery | Complications (e.g., hematoma, infection, flap necrosis) will be recorded and graded according to the Clavien-Dindo Classification System. The outcome is the count (and percentage) of participants experiencing at least one complication within the first postoperative year. These events are assessed at scheduled follow-up visits at 1, 3, 6, and 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wen Bin Zhou, professor | Contact | 13814162016 | zhouwenbin@njmu.edu.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39141399 | Background | Kim JH, Ryu JM, Bae SJ, Ko BS, Choi JE, Kim KS, Cha C, Choi YJ, Lee HY, Nam SE, Kim Z, Kang YJ, Lee MH, Lee JE, Park E, Shin HJ, Kim MK, Choi HJ, Kwon SU, Son NH, Park HS, Lee J; Korea Robot-endoscopy Minimal Access Breast Surgery Study Group. Minimal Access vs Conventional Nipple-Sparing Mastectomy. JAMA Surg. 2024 Oct 1;159(10):1177-1186. doi: 10.1001/jamasurg.2024.2977. | |
| 35915018 |
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|
| Endoscopic nipple-sparing mastectomy combined with prepectoral implant reconstruction | Procedure | This minimally invasive procedure is performed through small, concealed incisions in the axilla. Utilizing endoscopic instruments and an imaging system, the breast glandular tissue is resected under video monitoring, followed by reconstructive surgery with implant placement in the prepectoral plane. |
|
| within 1 year |
| Patient-reported quality of life as measured by Breast-Q reconstruction module | The Breast-Q reconstruction module assesses multiple domains, including psychosocial well-being, sexual well-being, physical well-being (of the chest and upper body), and satisfaction with breasts. All scores are transformed to a 0-100 scale. | 6 months and 1 year |
| Physician-assessed breast aesthetic score using a 5-point Likert scale | Independent surgeons will rate five specific domains (volume, shape, symmetry, scar, NAC) on a 5-point Likert scale (1=very dissatisfied to 5=very satisfied) using blinded photographs. The mean score for each domain and the composite mean score will be compared between groups. | 6 months and 1 year |
| Patient-reported quality of life as assessed by E0RTC QLQ-C30 | Patient-reported quality of life measured by E0RTC QLQ-C30, consists of 30 items grouped into functional scales, symptom scales and single items, global health status scale. Responses for most items are recorded on a 4-point Likert scale (1="Not at all" to 4="Very much"). The two Global Health Status items use a 7-point linear analogue scale (1="Very poor" to 7="Excellent"). Raw scores are linearly transformed to a standardized score ranging from 0 to 100 for each scale. For the functional scales and the global health status scale: a higher score indicates a better level of functioning or quality of life. For the symptom scales / single Items: a higher score indicates a greater severity of symptoms or problems. | 6 months and 1 year |
| Long-term breast skin sensation threshold as measured by Semmes-Weinstein Monofilaments | The mean pressure threshold, measured in grams using the Semmes-Weinstein monofilament test across nine standardized breast regions, will be compared between the conventional surgery group and the endoscopic surgery group after nipple-sparing mastectomy with prepectoral implant reconstruction for a long time. | Annually up to 10 years |
| Number of participants with postoperative complications as assessed by Clavien-Dindo Classification System after surgery in the long term. | Number of participants with postoperative complications assessed by Clavien-Dindo Classification System will be compared between two groups annually in the long term. | Annually up to 10 years |
| Long-term physician-assessed breast aesthetic score | Independent surgeons will rate five specific domains (volume, shape, symmetry, scar, NAC) on a 5-point Likert scale (1=very dissatisfied to 5=very satisfied) using blinded photographs. The mean score will be compared between groups at annual follow-ups. | Annually up to 10 years |
| Long-term patient-reported quality of life as measured by Breast-Q reconstruction module | The Breast-Q reconstruction module assesses multiple domains, including psychosocial well-being, sexual well-being, physical well-being (of the chest and upper body), and satisfaction with breasts. All scores are transformed to a 0-100 scale. The mean score will be compared between groups at annual follow-ups. | Annually up to 10 years |
| Long-term patient-reported quality of life as assessed by EORTC-QLQ-C30 | Long-term patient-reported quality of life measured by E0RTC QLQ-C30, consists of 30 items grouped into functional scales, symptom scales and single items, global health status scale. Responses for most items are recorded on a 4-point Likert scale (1="Not at all" to 4="Very much"). The two Global Health Status items use a 7-point linear analogue scale (1="Very poor" to 7="Excellent"). Raw scores are linearly transformed to a standardized score ranging from 0 to 100 for each scale. For the functional scales and the global health status scale: a higher score indicates a better level of functioning or quality of life. For the symptom scales / single Items: a higher score indicates a greater severity of symptoms or problems. | Annually up to 10 years |
| Background |
| Hammond JB, Kandi LA, Armstrong VL, Kosiorek HE, Rebecca AM, Casey WJ 3rd, Kruger EA, Cronin PA, Pockaj BA, Teven CM. Long-term breast and nipple sensation after nipple-sparing mastectomy with implant reconstruction: Relevance to physical, psychosocial, and sexual well-being. J Plast Reconstr Aesthet Surg. 2022 Sep;75(9):2914-2919. doi: 10.1016/j.bjps.2022.06.034. Epub 2022 Jun 20. |
| 37491239 | Background | Lai HW, Chang YL, Chandrachamnong K, See MH, Huang HI, Lin SL, Fang DY, Chen ST, Chen DR, Mok CW, Cheng FT. Factors associated with alteration of nipple or skin sensation and impact of duration of time following nipple-sparing mastectomy (NSM): an analysis of 460 cases with comparison of conventional versus endoscopic- or robotic-assisted NSM. World J Surg Oncol. 2023 Jul 26;21(1):222. doi: 10.1186/s12957-023-03107-5. |
| 38348883 | Background | Zhou J, Xie Y, Liang F, Feng Y, Yang H, Qiu M, Zhang Q, Chung K, Dai H, Liu Y, Liang P, Du Z. A novel technique of reverse-sequence endoscopic nipple-sparing mastectomy with direct-to-implant breast reconstruction: medium-term oncological safety outcomes and feasibility of 24-h discharge for breast cancer patients. Int J Surg. 2024 Apr 1;110(4):2243-2252. doi: 10.1097/JS9.0000000000001134. |
| 39700251 | Background | Seth AK, Sisco M. Prepectoral Breast Reconstruction. Plast Reconstr Surg. 2025 Jan 1;155(1):213e-227e. doi: 10.1097/PRS.0000000000011737. Epub 2024 Dec 16. |
| 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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