University of Wisconsin, Madison
This is a single-site, randomized, double-blinded trial to assess whether neurotization following autologous breast reconstruction in patients with breast cancer increases quality of life and sensation in the breast compared to breast reconstruction without neurotization. 50 participants will be enrolled and can expect to be on study for up to 18 months after reconstruction surgery.
Breast Reconstruction
Neurotization
Neurotization - Autologous Reconstruction with DIEP/TRAM
NA
In 2019, nearly one third of cancers diagnosed in the United States were breast cancers. Per the Plastic Surgery procedural statistics from the American Society of Plastic Surgery database, that same year approximately 107,000 patients decided to pursue either alloplastic (ex. Tissue expander or implant based) or autologous (ex. Transverse Rectus Abdominis Muscle (TRAM), Deep Inferior Epigastric Perforator (DIEP) flaps) breast reconstruction, an increase of 5% from 2018. Over the past few decades, as surgical techniques have continued to improve, postoperative concerns have transitioned towards the patient's aesthetic outcome and satisfaction. While the appropriate size, shape, and symmetry of the breast are crucial goals to achieve, another issue facing patients is that without sensation the reconstructed breast does not feel like their own. In most patients there is diminished, if not absent, sensation in the reconstructed breast. The lack of sensation can not only put patients at risk of injury, but also can impact their lives sexually and socially. The goal of this randomized, double-blinded study is to prospectively evaluate the impact of neurotization on breast-specific quality of life in patients who have undergone autologous reconstruction. Secondary objectives are to also look at additional health-related quality of life outcomes using validated surveys (e.g. PROMIS and NIH Toolbox). These NIH-funded surveys will be analyzed to assess factors important to surgical impact on physical function, mental function, social function, pain, and sexual function. Finally, investigators will objectively measure differences in sensation. Investigators hypothesize that breast neurotization will improve both breast- and health-related patient quality of life outcomes as well as objective sensation. The duration of this study is expected to be approximately 48 months in order to recruit an appropriate number of patients and have adequate postoperative follow up.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 50 participants |
| Masking : | DOUBLE |
| Primary Purpose : | SUPPORTIVE_CARE |
| Official Title : | The Effect of Neurotization on Quality of Life and Sensory Restoration After Autologous Breast Reconstruction |
| Actual Study Start Date : | 2025-03 |
| Estimated Primary Completion Date : | 2027-02 |
| Estimated Study Completion Date : | 2027-02 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | FEMALE |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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