MedTrace Logo

Comparison of Breast Sensory Recovery Between Conventional and Endoscopic Nipple-Sparing Mastectomy Combined With Prepectoral Implant Reconstruction

NCT07372339 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-01-28

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Conventional nipple-sparing mastectomy combined with prepectoral implant reconstruction

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.

PROCEDURE

Endoscopic nipple-sparing mastectomy combined with prepectoral implant reconstruction

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.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-03-31
Completion
2036-03-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07372339 on ClinicalTrials.gov