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Retrospective-prospective evaluation of complication rates, patient satisfaction and plastic surgery outcomes after primary implant-based breast reconstruction following mastectomy for breast cancer, ductal carcinoma in situ or high-risk genetic mutation

Retrospective-prospective evaluation of complication rates, patient satisfaction and plastic surgery outcomes after primary implant-based breast reconstruction following mastectomy for breast cancer, ductal carcinoma in situ or high-risk genetic mutation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00039161
Enrollment
487
Registered
2026-04-07
Start date
2026-04-13
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C50.9

Interventions

Group 1: This is a retrospective-prospective, single-center cohort study. Patient data are obtained from the hospital’s clinical information system (KIS), archived medical records, and the internally

Sponsors

Rotkreuzklinikum
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: Female patients aged 18 and over who are capable of giving informed consent and who received implant-based breast reconstruction following a mastectomy at the Breast Center of the Women's Clinic-Red Cross Clinics between 2017 and 2019.

Exclusion criteria

Exclusion criteria: Minors

Design outcomes

Primary

MeasureTime frame
Primary endpoint: Quality of life and patient satisfaction. Assessment of cosmetic outcomes from a plastic surgery perspective, depending on pre/subpectoral implant reconstruction.

Secondary

MeasureTime frame
Secondary endpoint: Complication and reoperation rates depending on the position of the implants (prepectoral versus subpectoral)

Countries

Germany

Contacts

Public ContactGitti Saadat

Rotkreuzklinikum München Frauenklinik

gitti.saadat@swmbrk.de089130339547

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026