Single-port nipple-sparing subcutaneous mastectomy with immediate prosthetic breast reconstruction for cancer
ISRCTN | ISRCTN13005336 |
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DOI | https://doi.org/10.1186/ISRCTN13005336 |
- Submission date
- 21/11/2022
- Registration date
- 30/12/2022
- Last edited
- 28/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Nipple-sparing subcutaneous mastectomy (NSM) combined with immediate prosthetic reconstruction (IPR) is an important surgery for breast cancer. Conventional open NSM-IPR (C-NSM-IPR) leaves long and ugly surgical scars on the skin, which are under the tension of the prosthesis. And this can result in incision splitting or prosthetic exposure. Some incisions around the areola could result in necrosis of the nipple-areola complex. A new surgical technique was designed called single-port insufflation endoscopic (SIE)-NSM-IPR to try to prevent these problems. The incision is short and is conducted on the lateral aspect of the chest wall. This allows the resection to be completed with an incision that is not in a high-tension area. The scar is short, which may improve its appearance and reduce surgical complications. This was a retrospective study that aimed to compare the oncologic safety, aesthetic outcome and perioperative results of SIE-NSM-IPR with those of C-NSM-IPR.
Who can participate?
Patients aged between 18 and 70 years old who received NSM-IPR between January 2014 and December 2019 at Beijing Friendship Hospital affiliated with Capital Medical University
What does the study involve?
This study investigated the oncologic safety, aesthetic outcome and perioperative results of two kinds of surgery, SIE-NSM-IPR and C-NSM-IPR using a questionnaire and data collected from the medical records.
What are the possible benefits and risks of participating?
This is a retrospective study. There are no benefits or risks to participating.
Where is the study run from?
Beijing Friendship Hospital, Capital Medical University (China)
When is the study starting and how long is it expected to run for?
November 2019 to November 2022
Who is funding the study?
1. Capital’s Funds for Health Improvement and Research (2020-2-1112) (China)
2. Research Foundation of Beijing Friendship Hospital, Capital Medical University (yyqdkt2018-11) (China)
Who is the main contact?
Guoxuan Gao, aliceggx@163.com
Contact information
Principal Investigator
Capital Medical University
No. 95, Yong An Road
Xicheng District
Beijing
100050
China
0000-0001-7115-5972 | |
Phone | +86 (0)1063138712 |
aliceggx@163.com |
Study information
Study design | Retrospective cohort study |
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Primary study design | Observational |
Secondary study design | Cohort study |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format |
Scientific title | Single-port nipple-sparing subcutaneous mastectomy with immediate prosthetic breast reconstruction for cancer: A retrospective cohort study (SPINER) |
Study acronym | SPINER |
Study objectives | Single-port insufflation endoscopic nipple-sparing subcutaneous mastectomy combined with immediate reconstruction using prosthesis implantation is safe with high quality of life for breast cancer patients |
Ethics approval(s) | Approved 26/05/2020, Ethics Committee of Beijing Friendship Hospital affiliated with Capital Medical University (95 Yong-an Road, Xi-Cheng District, Beijing 100050, China; +86 (10)-63139017; wykchangfeng@163.com), ref: 2019-P2-052-02 |
Health condition(s) or problem(s) studied | Breast cancer |
Intervention | This study was a retrospective cohort study. Single-port insufflation endoscopic nipple-sparing subcutaneous mastectomy combined with immediate prosthetic reconstruction (SIE-NSM-IPR) using prosthesis implantation was the test group. In this group, a small single-port incision on the side chest wall is used to perform resection of the gland and implant the prosthesis at the same time; this minimises the surgical scar and ensures that it is not in a high-tension area. Conventional open-nipple and areola-sparing subcutaneous mastectomy combined with immediate reconstruction using prosthesis implantation (C-NSM-IPR) was the control group, which leaves noticeable surgical scars on the surface of the breast. Patients underwent surgery for breast cancer between January 2014 and December 2019 at Beijing Friendship Hospital affiliated with Capital Medical University. Continuous variables with normal distribution will be reported as mean values (standard deviation [SD]). Non-normal variables will be presented as medians (interquartile range [IQR]). The means of two continuous normally distributed variables are compared using independent samples Student’s t-test. Mann-Whitney U test will be used to compare the means of 2 groups of variables not normally distributed. Log-rank tests will be used to compare the overall survival (OS) and disease-free survival (DFS) rates between the groups. A p-value less than 0.05 will be considered statistically significant. All reported p-values will be two-sided. The statistical analyses will be performed using SPSS v24 (IBM Corp., Chicago, IL, USA). |
Intervention type | Procedure/Surgery |
Primary outcome measure | Postoperative complications measured using data sources collected from the medical records according to the Clavien-Dindo classification 1 month after surgery |
Secondary outcome measures | 1. Aesthetic satisfaction of patients measured using the BREAST-Q questionnaire 6 months after surgery 2. Survival data measured using data sources collected from the medical records for all patients who were followed up at the outpatient clinic re-examination or through a telephone call every 6 months to record whether there was local recurrence or metastasis |
Overall study start date | 01/11/2019 |
Completion date | 01/11/2022 |
Eligibility
Participant type(s) | Patient |
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Age group | Mixed |
Sex | Female |
Target number of participants | 100 |
Total final enrolment | 64 |
Key inclusion criteria | 1. Aged between 18 to 70 years old 2. Diagnosis of stage I or II invasive breast carcinoma or carcinoma in situ 3. Original lesion ≤3 cm in diameter 4. Distance between the lesion and the nipple-areola complex ≥2 cm 5. Clinically negative axillary nodes 6. Tumor constrained to the mammary gland 7. Tumor is not invading the nipple-areola complex or the skin 8. Negative sentinel lymph node biopsy 9. Eastern Cooperative Oncology Group score from 0-2 10. Patient not suitable for breast-conserving surgery and not requesting mastectomy and breast reconstruction |
Key exclusion criteria | Positive sentinel lymph node biopsy |
Date of first enrolment | 01/01/2022 |
Date of final enrolment | 01/11/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Xicheng District
Beijing
100050
China
Sponsor information
Hospital/treatment centre
Capital Medical University
No. 95, Yong An Road
Xicheng District
Beijing
100050
China
Phone | +86 (0)10 63138585 |
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yyyyxczx@163.com | |
Website | http://www.bfh.com.cn/ |
https://ror.org/053qy4437 |
Government
Block B
Zhonghuan Office Building
70 Zaolinqian Street
Xicheng District
Beijing
100053
China
Phone | +86 (0)10 83970601 |
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qiuyujie@wjw.beijing.gov.cn | |
Website | http://wjw.beijing.gov.cn |
https://ror.org/0374a5s68 |
Funders
Funder type
Government
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- 首都医科大学 附属北京友谊医院, 北京友谊医院, Beijing Friendship Hospital, BFH
- Location
- China
Results and Publications
Intention to publish date | 01/11/2023 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
IPD sharing plan | The datasets generated during the current study will be available upon request from aliceggx@163.com. The type of data that will be shared: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Timing for availability: Beginning 12 months and ending 36 months following article publication Whether consent from participants was required and obtained: Yes Comments on data anonymization: All data were anonymized Any ethical or legal restrictions: Investigators whose proposed use of these data has been approved by an independent review committee identified for this purpose Any additional comment: No |
Editorial Notes
28/12/2022: Trial's existence confirmed by the Ethics Committee of Beijing Friendship Hospital affiliated with Capital Medical University.