Prospective cohort study to assess quality of life, surgical outcomes, and perioperative complications following implant-based breast reconstructio

• Conditions: C50.9; Breast, unspecified

• Registration Number: DRKS00034493
• Lead Sponsor: Rotkreuzklinikum München gGmbH - Hauptabteilung Gynäkologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 308

Inclusion Criteria

i. >18 years old, fully capable of giving consent
ii. Signed informed consent form
iii. Histologically confirmed breast carcinoma or precancerous lesion (DCIS/LCIS) or genetic high-risk mutation, each with an indication for mastectomy and planned implant-based reconstruction

Exclusion Criteria

None defined, as this is not an interventional study. All patients will be treated according to guidelines.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of Life, measured using the BreastQ at 3 years after surgery

Secondary Outcome Measures

Name	Time	Method
Quality of life, measured using the BreastQ at 1 year and 5 years<br>Surgical outcome (photo analysis with bcct.core and structured clinical examination) at 1, 3 and 5 years post-operation<br>Complications/reoperations perioperatively, up to 1 year and up to 3 and 5 years post-operation