Psychological Effects of Implant Loss

Vastra Gotaland Region

Status: Completed

Conditions: Breast Cancer Female

Study type: Observational

Funder types: Other

Identifiers

NCT04503018

2019-06214

Details and patient eligibility

About

Previous quality of life studies have suggested that long term satisfaction with breast reconstruction may be affected by postoperative complications. Complication frequencies, especially the risk for implant loss, is considerably higher in immediate than in delayed breast reconstruction. Knowledge about how implant loss affects the patient's experience of her breast reconstruction can guide us in the choice between immediate and delayed breast reconstruction in high risk patients and help us better prepare the patients for possible complications. This study will investigate patients' experiences with losing an implant in connection with immediate breast reconstruction.

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biological women
• Age >18 years
• Have lost an implant after a mastectomy and immediate breast reconstruction

Exclusion criteria

• Inability to give informed consent
• inability to speak and understand Swedish
• relapse of breast cancer after the reconstruction
• metastatic disease
• psychiatric co-morbidity.

Trial design

150 participants in 3 patient groups

Interviewed -implant loss

Description:

Patients who have had immediate breast reconstruction and lost the implant due to for example infection.

Questionnaires - implant loss

Description:

Patients who have had immediate breast reconstruction and lost the implant due to for example infection.

Questionnaires - controls

Description:

Patients who have had immediate breast reconstruction without complications