Comparing two methods of breast reconstruction after mastectomy
Autologous vs. Implant-based Breast Reconstruction: a Partially Randomised Patient Preference, Superiority Trial
This study is testing whether a natural tissue method or an implant method for breast reconstruction after mastectomy works better for women in terms of satisfaction and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 2 sites (Gothenburg and 1 other locations) |
| Trial ID | NCT06195865 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of autologous breast reconstruction using the DIEP-flap technique versus implant-based breast reconstruction in patients who have undergone mastectomy for breast cancer. It focuses on patient-reported outcomes related to breast-specific quality of life and satisfaction, while also assessing complications, factors influencing satisfaction, and cost-effectiveness. The study employs a partially randomized patient preference trial design to address challenges in recruitment and bias typically associated with randomized controlled trials. Participants will be non-radiated biological females over 18 years of age who can communicate in Swedish.
Who should consider this trial
Good fit: Ideal candidates are biological females over 18 years old who are scheduled for a mastectomy and have an ASA classification of 1-2.
Not a fit: Patients with ASA classification greater than 2, those with a BMI over 30 kg/m2, or those who have had prior radiotherapy to the breast in question may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the most effective breast reconstruction method, enhancing patient satisfaction and quality of life.
How similar studies have performed: While there have been studies comparing breast reconstruction methods, this approach using a partially randomized patient preference trial design is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Gothenburg and 1 other locations
- Sahlgrenska university hospital — Gothenburg, Sweden (Recruiting)
- Sahlgrenska university hospital — Gothenburg, Sweden (Recruiting)
Study contacts
- Study coordinator: Emma Hansson, PhD
- Email: emma.em.hansson@vgregion.se
- Phone: +46313421000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.