Single-port nipple-sparing subcutaneous mastectomy with immediate prosthetic breast reconstruction for cancer

ISRCTN ISRCTN13005336
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Guoxuan Gao
Principal Investigator

Capital Medical University
No. 95, Yong An Road
Xicheng District
Beijing
100050
China

ORCiD logoORCID ID 0000-0001-7115-5972
Phone +86 (0)1063138712
Email aliceggx@163.com

Study information

Study designRetrospective cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format
Scientific titleSingle-port nipple-sparing subcutaneous mastectomy with immediate prosthetic breast reconstruction for cancer: A retrospective cohort study (SPINER)
Study acronymSPINER
Study objectivesSingle-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) studiedBreast cancer
InterventionThis 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 typeProcedure/Surgery
Primary outcome measurePostoperative complications measured using data sources collected from the medical records according to the Clavien-Dindo classification 1 month after surgery
Secondary outcome measures1. 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 date01/11/2019
Completion date01/11/2022

Eligibility

Participant type(s)Patient
Age groupMixed
SexFemale
Target number of participants100
Total final enrolment64
Key inclusion criteria1. 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 criteriaPositive sentinel lymph node biopsy
Date of first enrolment01/01/2022
Date of final enrolment01/11/2022

Locations

Countries of recruitment

  • China

Study participating centre

Beijing Friendship Hospital affiliated with Capital Medical University
No. 95, Yong An Road
Xicheng District
Beijing
100050
China

Sponsor information

Beijing Friendship Hospital
Hospital/treatment centre

Capital Medical University
No. 95, Yong An Road
Xicheng District
Beijing
100050
China

Phone +86 (0)10 63138585
Email yyyyxczx@163.com
Website http://www.bfh.com.cn/
ROR logo "ROR" https://ror.org/053qy4437
Beijing Municipal Health Bureau
Government

Block B
Zhonghuan Office Building
70 Zaolinqian Street
Xicheng District
Beijing
100053
China

Phone +86 (0)10 83970601
Email qiuyujie@wjw.beijing.gov.cn
Website http://wjw.beijing.gov.cn
ROR logo "ROR" https://ror.org/0374a5s68

Funders

Funder type

Government

Capital’s Funds for Health Improvement and Research

No information available

Beijing Friendship Hospital, Capital Medical University
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 date01/11/2023
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal
IPD sharing planThe 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.