Comparison Between Prepectoral and Subpectoral Breast Reconstruction

NCT05833659 | Recruiting

• 1 other identifier: RESPECT
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

There are controversies about breast implant-based reconstruction techniques. Our center pioneered single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) combined with stage I prosthesis reconstruction. The study's primary objective is to compare single-port endoscopic NSM combined with pre-pectoral breast reconstruction to the subpectoral breast reconstruction group regarding breast satisfaction. This study is an ambispective cohort study. The study will be conducted at Beijing Friendship Hospital, affiliated with Capital Medical University. Patients will be enrolled retrospectively from January 2014 to March 2022 by reviewing the medical records and recruited prospectively from March 2022 to March 2025. The two cohorts are the pre-pectoral breast reconstruction cohort and the subpectoral breast reconstruction cohort, both following single-port insufflation endoscopic nipple-sparing mastectomy. The primary outcome of this study is postoperative breast satisfaction, which the BREAST-Q score will measure. The different variables will be compared using the Χ2 test for categorical variables and the Mann-Whitney test for continuous variables.

Conditions

Stage II Breast Cancer; Stage I Breast Cancer

Keywords

breast cancer; endoscopic nipple-sparing mastectomy; breast reconstruction; breast satisfaction; BREAST-Q score

Outcome Measures

Primary Outcomes (1)

• breast satisfaction

  measured by BREAST-Q score

  12 months after operation

Secondary Outcomes (4)

• Physical well-being of chest

  12 months after operation

• Animation deformity

  12 months after operation

• Adverse events

  within 30 days after surgery

• Local recurrence and distant metastasis of breast cancer

  12 months after operation

Study Arms (2)

The prepectoral breast reconstruction

The patients received prepectoral breast reconstruction after single-port insufflation endoscopic nipple-sparing mastectomy

Procedure: The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy

The subpectoral breast reconstruction

The patients received subpectoral breast reconstruction after single-port insufflation endoscopic nipple-sparing mastectomy

Procedure: The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy

Interventions

The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy PROCEDURE

Group A:The prepectoral breast reconstruction. Group B:The subpectoral breast reconstruction

The prepectoral breast reconstruction; The subpectoral breast reconstruction

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) and having willingness for breast reconstruction.

You may qualify if:

• Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) by core needle biopsy.
• Breast-conserving surgery is not possible due to the presence of contraindications to breast-conserving surgery, or the patient actively requests total mastectomy.
• Patients having willingness for breast reconstruction.
• Age between 18 to 70 years.
• Maximum diameter of the cancer lesion ≤ 3 cm.
• Physical examination and breast magnetic resonance imaging (MRI) confirmed that the tumor did not invade the skin, subcutaneous tissue, or chest wall.
• The distance between the lesion and the nipple is ≥2 cm, and it is confirmed by physical examination and MRI that the nipple-areola complex is not invaded.
• Eastern Cooperative Oncology Group (ECOG) Performance Status Scale of 0 to 2.

You may not qualify if:

• patients having serious medical diseases, including unstable angina pectoris, myocardial infarction, and cerebrovascular accident within 6 months.
• Having history of malignant tumor (s) within 5 years.
• Patients under immunosuppressive therapy for organ transplantation.
• Having continuous systemic steroid hormone therapy.
• Pregnant or lactating women.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead
• Beijing Health Promotion Association: collaborator

Study Sites (1)

Beijing Friendship Hospital, Capital medical University

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• guoxuan gao, MD

  Department of General Surgery, Beijing Friendship Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

guoxuan gao, MD

CONTACT

+861063138712; aliceggx@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2023
• First Posted: April 27, 2023
• Study Start: March 1, 2022
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

CN (1)