Effect of Neurotization on QoL and Sensory Restoration

University of Wisconsin (UW)

Status

Withdrawn

Conditions

Breast Reconstruction

Neurotization

Treatments

Procedure: Neurotization - Autologous Reconstruction with DIEP/TRAM

Study type

Interventional

Funder types

Other

Identifiers

NCT05206565

A539730 (Other Identifier)

Protocol Version 9/29/2021 (Other Identifier)

UW21028 (Other Identifier)

2021-0290

Details and patient eligibility

About

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.

Full description

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Willing to provide informed consent
The patient is ≥ 18 years
Patients presenting to UW Health who have had or will have unilateral or bilateral mastectomy (therapeutic or prophylactic) and are planning to undergo autologous reconstruction with TRAM/DIEP will be included

Exclusion criteria

Patient is non-English speaking
Patient is known or believed to be pregnant
Patient is a minor (individuals <18 years old)
Patient is a prisoner
Individuals unable to give consent due to another condition such as impaired decision-making capacity
Autologous reconstruction where the flap is buried (e.g. there is no autologous skin exposed for sensation testing)
Patient is a male
Any patient with: diabetic neuropathy, thyroid disorders, collagen vascular disease, alcoholism, pernicious anemia, or any other severe underlying peripheral neuropathy
Women with recurrent breast cancer
Women who have undergone previous breast reconstructive procedures
Not suitable for study participation due to other reasons at the discretion of the investigators
Patient is currently lactating
History of radiation therapy
Patient undergoing a latissimus dorsi flap for reconstruction
Patient undergoing alloplastic reconstruction