Status:
RECRUITING
Autologous vs. Implant-based Breast Reconstruction
Lead Sponsor:
Vastra Gotaland Region
Collaborating Sponsors:
Göteborg University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Although breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective. The objective of this study is to c...
Eligibility Criteria
Inclusion
- Biological female
- \>18 years of age
- American Society of anesthesiologist classification (ASA) 1-2
- Patient must have had or be scheduled for a mastectomy
- Ability to give informed consent
- Ability to communicate in Swedish
Exclusion
- ASA \> 2
- BMI \> 30 kg/m2
- Smoking1 radiotherapy to the breast in question.
- Radiotherapy is expected post-operatively.
- Locally advanced breast cancer
- Metastasised breast cancer
- Comorbidity and/or drugs that affect wound healing.
- Unstable psychiatric co-morbidity
- Abdominal scaring/chest scaring making a DIEP/implant-based reconstruction unsuitable
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06195865
Start Date
April 1 2024
End Date
December 31 2031
Last Update
July 3 2025
Active Locations (2)
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1
Sahlgrenska university hospital
Gothenburg, Sweden, 413 45
2
Sahlgrenska university hospital
Gothenburg, Sweden