NCT06195865 Autologous vs. Implant-based Breast Reconstruction
| NCT ID | NCT06195865 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2024-04-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 compare implant-based and autologous breast reconstruction, in non-radiated patients. The primary outcome is patient reported breast-specific quality of life/satisfaction and the secondary outcomes are complications, factors affecting satisfaction, and cost-effectiveness. Moreover, the study aims to improve the evidence for trial decision-making in breast reconstruction. Randomized controlled trials (RCT) are generally thought to provide the most solid scientific evidence, but there are significant barriers to conducting RCTs in breast reconstruction, making both recruitment and achieving unbiased and generalisable results a challenge. The study design partially randomised patient preference trial (RPPT) might be a way to overcome these challenges. In the present study, patients who consent to randomisation will be randomised to implant-based and autologous breast reconstruction, whereas patients with strong preferences will be able to choose method. The study is designed as a superiority trial based on BREAST-Q and 124 participants will be randomised. In the preference cohort patients will be included until 62 participants have selected the least popular alternative. Follow-up will be 60-months. Embedded qualitative studies and within-trial economic evaluation will be performed.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06195865 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06195865 currently recruiting?
Yes, NCT06195865 is actively recruiting participants. Contact the research team at emma.em.hansson@vgregion.se for enrollment information.
Where is the NCT06195865 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Gothenburg, Sweden.
Who is sponsoring the NCT06195865 clinical trial?
NCT06195865 is sponsored by Vastra Gotaland Region. The trial plans to enroll 250 participants.
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