Comparing two methods of breast reconstruction after mastectomy
Official title: Autologous vs. Implant-based Breast Reconstruction: a Partially Randomised Patient Preference, Superiority Trial
Run by Vastra Gotaland Region · NCT06195865 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 250 (estimated) |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 2 sites (Gothenburg and 1 other locations) |
| Status | Recruiting |
| Started | April 1, 2024 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2031 |
| Registry record updated | July 3, 2025 |
| Trial ID | NCT06195865 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While there have been studies comparing breast reconstruction methods, this approach using a partially randomized patient preference trial design is relatively novel.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.