Breast Reconstruction in Previously Irradiated Breast

Completed

• Conditions: Breast Implant; Complications; Mammaplasty; Transplant Failure; Radiotherapy; Complications
• Interventions: Radiation: Pre reconstruction Radiotherapy

• Registration Number: NCT04854525
• Lead Sponsor: Humanitas Clinical and Research Center

Brief Summary

For patients with breast cancer subject to a mastectomy, preserving the morphology of the breast with immediate reconstruction is a crucial aspect to preserve the quality of life.

There are several types of breast reconstruction: prosthetic in one or two stages and autologous reconstruction.

Adjuvant radiotherapy has shown an improvement of the overall survival and of the local control for patients with positive lymph nodes. As a consequence, plastic surgeons come into contact with more patients with a history of irradiation of their breasts than ever before.

However, there are few studies with a significant number that evaluate the effect of pre-reconstruction radiotherapy on the three types of reconstruction.

The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the impact of breast prior irradiation on the outcome of prosthetic reconstruction.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-06
• Primary Completion: 2020-11-23
• Study Completion: 2021-01-25
• Study First Submitted: 2021-03-24
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-21
• Last Update Submitted: 2021-04-21
• Study First Posted: 2021-04-22
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2150

Inclusion Criteria

• Patients subjected to mastectomy and immediate reconstruction directly with prostheses, in two times and by autologue flaps (TRAM, Latissimus Dorsi Flap, DIEP and any other method)

Exclusion Criteria

• Delayed prosthetic reconstruction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Autologous Reconstruction With pre-reconstruction Radiotherapy	Pre reconstruction Radiotherapy	-
One Stage Reconstruction With pre-reconstruction Radiotherapy	Pre reconstruction Radiotherapy	-
Two Stage Reconstruction With pre-reconstruction Radiotherapy	Pre reconstruction Radiotherapy	-

Primary Outcome Measures

Name	Time	Method
Reconstruction failure	2 years	Complication rate (as hematoma, seroma, prosthetic exposure, skin and fat necrosis) that resulted in explant (prosthetic, expander or flap)

Secondary Outcome Measures

Name	Time	Method
Reconstruction Complications	2 years	Rate of need for reintervention

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milan, Italy