Psychological Effects of Implant Loss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Expectations and Body Image in Breast Reconstruction

NCT04714463

Breast Cancer

RECRUITING

Breast Reconstruction

NCT06332937

Breast Implant; Complications

ACTIVE_NOT_RECRUITING

Autologous vs. Implant-based Breast Reconstruction

NCT06195865

Breast Cancer

RECRUITING NA

Complications and Long-term Satisfaction in Autologous vs. Implant-Based Breast Reconstruction

NCT06295042

Complications, Postoperative/Perioperative Quality of Life Satisfaction, Patient

COMPLETED

Patient Preferences for Breast Reconstruction After Mastectomy

NCT01488357

Breast Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Female

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Interviewed -implant loss

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

No interventions assigned to this group

Questionnaires - implant loss

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

No interventions assigned to this group

Questionnaires - controls

Patients who have had immediate breast reconstruction without complications

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No