Data Collection of Prepectoral Breast Reconstruction With Polyurethane Implantes (IBR-PPBR)

European Institute of Oncology

Status: Completed

Conditions: Breast Reconstruction; Prepectoral Breast Reconstruction; Radiation Therapy Complication

Treatments: Procedure: Prepectoral breast reconstruction with polyurethane implants

Study type: Observational

Funder types: Other

Identifiers

NCT06216106

UID 4260

Details and patient eligibility

About

The goal of this observational study is to learn about correct surgical indications and long-term complications in patient with immediate prepectoral breast reconstruction with polyurethane implants. The main question it aims to answer are: what are the correct indications for this type of reconstruction? what is the complications rates? are the complications affected by pre and post operative radiotherapy? It's a retrospective study of all the patients that received prepectoral breast reconstruction with polyurethane implants without any exclusion factors. Researchers will compare the non-irradiated group with the patients with pre and post radiation therapy.

Full description

The study is a data collection of 250 patients for a total of 317 breasts underwent prepectoral breast recosntruction with polyurethane implantes. It is a retrospective study of a single center. The investigators gave indication to that type of reconstruction only to patients with good thickness (> 0.5 cm) and vascularity of skin flap after mastectomy.

The investigators used not selective criteria regarding risk factors so to better evaluate wich of them has a negative trend on the success of the reconstruction and on the major and minor complications. In that way the investigators tried to definde clarly the correct indications for this type of reconstruction.

In addition, the investigators would like to define if the postoperative radiation therapy agument the complications rate and the capsular contracture incidence.

The investigators decide to perform prepectoral breast reconstruction also in 20 patientes underwent previous radiotherapy dependig on the grade of cutaneus radiodistrophy, so to propose our less invasive approach to these patients normally candidates to autologus breast reconstruction

Enrollment: 237 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients underwent prepectoral breast recosntruction with polyurethane implants after skin or nipple sparing masectomy
• adequate mastectomy flap in vascularity and thickness

Exclusion criteria

• none

Trial design

237 participants in 1 patient group

patients undergone prepectoral breast reconstruction

Description:

As the retrospective nature of this study, we have no exlusion criterias. We included all the patients with prepectoral breast reconstruction with polyurethane covered implants. We also included patients underwent postoperative radiation therapy (50 patients) and 20 patients with history of previous radiotherapy

Treatment:

Procedure: Prepectoral breast reconstruction with polyurethane implants