RecruitingNCT07037576

Efficacy and Safety of Prepectoral Prosthesis Immediate One-Stage Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients: A Prospective, Single-Center, Cohort Study


Sponsor

Henan Cancer Hospital

Enrollment

104 participants

Start Date

May 20, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Prospective Evaluation of the Efficacy and Safety of Prepectoral Immediate One-Stage Prosthetic Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study compares two methods of breast reconstruction after mastectomy in women who also need radiation therapy: placing the implant in front of the chest muscle in one step (prepectoral) versus a two-step process using a temporary tissue expander first. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have newly diagnosed breast cancer with no evidence of distant spread - You need radiation therapy after surgery - You are scheduled for a nipple-sparing or skin-sparing mastectomy **You may NOT be eligible if...** - You have had previous radiation to the chest - You have distant metastases - Your body shape or health status makes one-step reconstruction unsuitable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBreast Reconstruction Surgery

Breast Reconstruction Surgery (either immediate one-stage prepectoral implant reconstruction or two-stage expander/implant reconstruction) with postoperative adjuvant radiotherapy


Locations(1)

Henan cacer hospital

Henan, Henan, China

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NCT07037576


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