An interventional study of robotic assisted nipple sparing mastectomy and Endoscopic assisted nipple sparing mastectomy in Breast Cancer Female, sponsored by Changhua Christian Hospital. Status unknown at 11 sites in Taiwan. Open to female participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-09-13.
Sponsored by Changhua Christian Hospital · Not applicable, Interventional, and Treatment
This study will prospectively evaluate the surgical outcomes of robotic nipple sparing mastectomy (NSM) compared with endoscopic assisted NSM or conventional NSM in the management of breast cancer. One-third patients would received R-NSM, another one-third received C-NSM while the other one-third would receive E-NSM.
Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy, was increasingly performed in breast cancer patients due to better cosmetic outcome, higher patient satisfaction, and maintained oncologic safety.
Minimal invasive surgery had become the main stream of operations, and new surgical innovations of NSM, like endoscopic nipple sparing mastectomy (E-NSM) or robotic nipple sparing mastectomy (R-NSM), were emerging and applied in the surgical treatment of breast cancer.
E-NSM, which is performed through small axillary and/or peri-areolar incisions, was reported to be associated with small inconspicuous incision and good cosmetic outcome. Conventional E-NSM was performed with two separate incisions over axilla and peri-areolar regions. E-NSM with areolar incision, just like NSM with areolar related incision (NAC ischemia/necrosis rate: range 7%-81.8%), was associated with increased NAC ischemia/necrosis (reported ranged: 9.1-19%). New technique modifications of E-NSM were emerging focusing on single axillary incision NSM, which spare the peri-areolar incision and thereby decrease the compromise of bloody supply from mastectomy skin flap, was reported to have low NAC necrosis rate (0%).
However, the 2-dimensional endoscopic in-line camera produces an inconsistent optical window around the curvature of the breast skin flap, and the internal mobility was limited and the dissection angles were inadequate with traditional endoscopic rigid tips instruments through single access. Due to the limitations of endoscopy instruments and technique difficulty, neither conventional E-NSM nor single access E-NSM was widespread used in breast cancer
R-NSM, which introduce da Vinci surgical platform through a small extra-mammary axillary or lateral chest wound to perform NSM, had been applied in the surgical treatment of early breast cancer or risk reducing mastectomy. R-NSM, which incorporated 3-dimensional (3D) imaging system and flexibility of robotic arm and instruments, was reported to have the potential to overcome the technique difficulty of E-NSM.
The preliminary results of R-NSM from current reported series and ours were safe, and associated with good cosmetic outcome and high patients' satisfaction. However, evidence comparing R-NSM to conventional NSM (C-NSM) or E-NSM was lacking.
In this study, the authors aim to investigate and analyze the clinical and aesthetic outcomes as well as the cost effectiveness of R-NSM through a prospective cohort of patients undergoing R-NSM, E-NSM or C-NSM.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 180 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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B. Indications and selection criteria for robotic nipple sparing mastectomy (R-NSM) or endoscopic nipple sparing mastectomy (E-NSM)
Exclusion Criteria:
R-NSM, which introduce da Vinci surgical platform through a small extra-mammary axillary or lateral chest wound to perform NSM.
Device: robotic assisted nipple sparing mastectomy
Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy.
Procedure: Conventional nipple sparing mastectomy
E-NSM, which is performed through small axillary and/or peri-areolar incisions, with endoscopic instruments to performed nipple sparing mastectomy.
Procedure: Endoscopic assisted nipple sparing mastectomy
R-NSM, which introduce da Vinci surgical platform through a small extra-mammary axillary or lateral chest wound to perform NSM, had been applied in the surgical treatment of early breast cancer or risk reducing mastectomy. R-NSM, which incorporated 3-dimensional (3D) imaging system and flexibility of robotic arm and instruments, was reported to have the potential to overcome the technique difficulty of E-NSM.
E-NSM, which is performed through small axillary and/or peri-areolar incisions, was reported to be associated with small inconspicuous incision and good cosmetic outcome. Conventional E-NSM was performed with two separate incisions over axilla and peri-areolar regions. E-NSM with areolar incision, just like NSM with areolar related incision (NAC ischemia/necrosis rate: range 7%-81.8%), was associated with increased NAC ischemia/necrosis (reported ranged: 9.1-19%). New technique modifications of E-NSM were emerging focusing on single axillary incision NSM, which spare the peri-areolar incision and thereby decrease the compromise of bloody supply from mastectomy skin flap, was reported to have low NAC necrosis rate (0%).
Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy, was increasingly performed in breast cancer patients due to better cosmetic outcome, higher patient satisfaction, and maintained oncologic safety.
Operation time
Overall operation time (minute), including breast cancer operations, lymph node surgery, and breast reconstructions
Time frame: immediate post operation
Morbidity and complications
Delayed wound healing, degree of nipple ischemia/necrosis, seroma formation needing repeated aspiration, Blister formation, Skin flap ischemia necrosis, Hematoma formation, Implant loss will be collected and analyzed between different R-NSM, C-NSM and E-NSM groups.
Time frame: within one month (30 days) post operation
Nipple areolar complex ischemia/necrosis grading
To evaluate the post-operative perfusion and survival of nipple areolar complex (NAC), a grading system was used in current study. The perfusion of NAC was evaluated in 2 weeks to 3 months post operation. The survival of NAC was confirmed at post-operative 3 months. The NAC ischemia/necrosis was divided into 5 different grades, which were: 1. No ischemia/necrosis was observed in NAC (Grade I). 2. Transient ischemia recovered without necrosis (Grade II). 3. Partial ischemia/necrosis, recovered without loss of nipple volume (Grade III). 4. Partial NAC necrosis with partial volume loss of nipple (Grade IV). 5. Total NAC necrosis with all volume loss of nipple (Grade V). NAC ischemia/necrosis was segregated into no NAC necrosis (Grade I-III) and NAC necrosis (Grade IV-V). The ischemia/necrosis of NAC between different R-NSM, C-NSM and E-NSM groups were recorded and compared.
Time frame: evaluated in post operative 2 weeks to 3 months post operation
Surgical margin involvement
Surgical margin involvement was defined as tumor on the ink. The postoperative adjuvant hormone therapy, chemotherapy and radiotherapy were given to patients according to current breast cancer guidelines.
Time frame: post operative 2 weeks after pathologic report available
Aesthetic outcome evaluation-Patient reported cosmetic outcome results
- Post-operative aesthetic results will be evaluated by comparing pre-operative and post-operative results. A self-reported questionnaire to evaluate the cosmetic outcome of breast cancer patients with mastectomy following breast reconstruction was conducted 1-3 months after the operation. This questionnaire comprises of 10 questions based on 4 itemized scales, which will be graded as "1, dis-satisfied", "2, fair", "3, satisfied", and "4, very satisfied".
Time frame: 1-3 months after the operation when the wound was healed
Blood loss during operations
Blood loss (ml) from skin incision to completion of operations
Time frame: immediate post operation
Hospital stay
Hospital stay (days) during operation period, recorded from admission to day of discharge at the breast cancer operation.
Time frame: within 2 weeks of operation
Resection mastectomy weight
Mean mastectomy weight (gm) of patients received different mastectomy operations
Time frame: immediate post operation
Reconstruction implant volume
Reconstruction implant volume (ml)
Time frame: immediate post operation
Pain assessments
Pain assessments will also be collected as part of the post-operative parameters. Visual analogue scale (VAS) for pain assessments will be used in this study (range from 0 to 10 points, 0 indicate no pain, 10 indicate maximal pain ever experienced). VAS for pain per day would be recorded very day and compared.
Time frame: within post operation two weeks
Cost- analysis of C-NSM versus R-NSM or E-NSM
The medical cost associated with robotic versus conventional or endoscopic assisted NSM will be collected and compared. The medical cost incurred for each procedure include overall hospital cost. Information on surgery-related expenses will obtained from the finance department of the institution. In Taiwan, the operation fees of breast reconstruction and robotic breast surgery are not reimbursed by national insurance. * The medical cost covered by national insurance include operations fee for breast cancer and/or axillary lymph node surgery, anesthesia, admission fee, and all other medical related expenses. * The medical cost not reimbursed by national insurance, and needed to be paid for by patients include fees for breast reconstruction, robotic breast surgery, endoscopic breast surgery, instruments and prosthetic implants. * Cost is expressed in New Taiwan dollars (NTDs) and in United States dollars (USDs). An exchange rate of 31 NTD/USD was used to convert NTD to USD.
Time frame: post operation one month
Disease free survival
any local regional recurrence, or distant metastasis was recorded as an event. Disease free survival would be compared between R-NSM, C-NSM and E-NSM groups
Time frame: 5 years post operation
Overall Survival
overall survival would be compared between R-NSM, C-NSM and E-NSM groups
Time frame: 5 years post operation
Plan to share: No
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Changhua Christian Hospital