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Quality of life after bilateral risk-reducing mastectomy and simultaneous reconstruction using pre-pectoral silicone implants, a prospective single centre analysis

Quality of life after bilateral risk-reducing mastectomy and simultaneous reconstruction using pre-pectoral silicone implants, a prospective single centre analysis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00024043
Enrollment
38
Registered
2021-01-15
Start date
2018-07-01
Completion date
Unknown
Last updated
2025-04-07

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: Examination of quality of life before and after surgery using the SF-36 and the Breast-Q questionnaire. Patients underwent mastectomy and simultaneous breast reconstruction using a silicone

Sponsors

Universitätsklinik Leipzig
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: diagnosis of a gene mutation predisposing to breast cancer; SSM or NSM with a simultaneous pre-pectoral implant-based reconstruction; and age =18 years

Exclusion criteria

Exclusion criteria: The exclusion criteria were as follows: patients with current cancer and/or on cancer therapy and patients who needed translation assistance for verbal consent and age <18 years.

Design outcomes

Primary

MeasureTime frame
Mutation carriers of breast cancer who underwent risk-reducing mastectomy and simultaneous breast reconstruction with an implant. The influence of immediate reconstruction on the patients' psyche was to be determined. The patients' quality of life was recorded. Pre-operative quality of life was assessed by the "Breast Q Pre-Op" questionnaire, 2 years after surgery it was evaluated by the "Post-Op Breast Q Questionnaire" and the SF 36. Identification of risk factors through the evaluation of data collected in clinical routine. Translated with www.DeepL.com/Translator (free version)

Secondary

MeasureTime frame
Wound healing disorders that occurred during the course as well as capsular fibrosis (Baker) and sensory disturbances were recorded.

Countries

Germany

Contacts

Public ContactNick Spindler

Universität Leipzig

nick.spindler@medizin.uni-leipzig.de+493419717145

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026