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Breast Neoplasms

Breast Diseases

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Patients who have undergone mastectomy Patients who have undergone immediate, twostage expander/implant breast reconstruction; Patients who have undergone immediate, autogenous tissue flap reconstruction including: pedicled and/or free TRAM flap or DIEP flap reconstruction

A physical examination of your breast(s), we will ask you to complete a short questionnaire that asks questions regarding sensations in your reconstructed breast(s) and another short questionnaire that asks questions regarding your medical and surgical history. The physical examination and the questionnaires will be completed in the outpatient clinic. This should take about 30 minutes to complete.

breast exam and questionaire

Babak Mehrara, MD

The purpose of this study is to evaluate the return of sensation in the breast(s) following breast mastectomy with and without reconstruction. Four different sensations: touch, vibration, superficial pain, and temperature will be evaluated. In addition, we will look at factors that may contribute to the return of breast sensations.

This study entitled "The Quantification of Breast Sensations Following Postmastectomy Breast Reconstruction" will evaluate the recovery of sensation in the reconstructed as well as in the nonreconstructed breast. Touch, vibration, pain and temperature sensation will be objectively evaluated greater than 1 year following completion of reconstruction. Breast sensation following immediate, tissue expander/implant breast reconstruction will be compared with that following immediate, autogenous tissue reconstruction.

A formal sensory examination will be performed. SemmesWeinstein monofilaments will evaluate touchpressure sensation in the breast. A Bioesthesiometer will determine the recovery of vibratory sensation. Temperature sensation will be evaluated by application of warm and cool stimuli. Superficial pain sensation will be evaluated by application of sharp and dull stimuli.

A patient reported assessment of sensory changes in the breast will be administered to patients. The Breast Sensation Assessment Scale © is designed to measure the prevalence, severity, and distress of 18 different sensory symptoms following breast surgery. A "Patient Demographic and Treatment Information Form" and patients' medical records will be used to obtain demographic and treatment data. The role of confounding variables (including: patient age, breast volume, axillary procedures performed and adjuvant therapies received) on the recovery of sensation will be evaluated.

The estimated accrual time for this study is 12 months.

Quantification of Breast Sensation Following Postmastectomy Breast Reconstruction

Memorial Sloan Kettering Cancer Center

Patients in this group underwent immediate or delayed, unilateral or bilateral lateral thigh perforator (LTP) flap breast reconstruction with additional sensory nerve coaptation.

Patients in this group underwent immediate or delayed, unilateral or bilateral lateral thigh perforator (LTP) flap breast reconstruction without sensory nerve coaptation.

A recipient sensory nerve branch of the lateral cutaneous femoral nerve (LCFN) was reattached to a donor nerve in the chest area. The anterior cutaneous branch of the second or third intercostal nerve was used as the donor nerve. Direct, end-to-end nerve coaptation was performed.

Sensory nerve coaptation

René van der Hulst, MD, PhD

The sensory recovery of the breast remains an undervalued aspect of breast reconstruction and surgical reinnervation is not regarded as a priority by most reconstructive surgeons. A prospective study was conducted of all patients who underwent either innervated or non-innervated lateral thigh perforator (LTP) flap breast reconstruction in Maastricht University Medical Center and returned for follow-up between February 2016 and April 2019. Semmes-Weinstein monofilaments were used for sensory testing of the breast.

Nerve Coaptation in LTP Flap Breast Reconstruction

Sensory Recovery of the Breast Following Innervated and Non-innervated Lateral Thigh Perforator (LTP) Flap Breast Reconstructions

The sensory recovery of the breast to touch was tested at different follow-up moments after the initial surgery. Semmes-Weinstein monofilaments were used for sensory testing. Nine areas of the breast, indicating native skin and flap skin, were tested. Mean monofilament values were calculated for each area and compared between groups.

Maastricht University Medical Center

Head of the Plastic Surgery department

Patients in this group underwent immediate or delayed, unilateral or bilateral DIEP flap breast reconstruction with additional sensory nerve coaptation.

Patients in this group underwent immediate or delayed, unilateral or bilateral DIEP flap breast reconstruction without sensory nerve coaptation.

A recipient sensory nerve branch of the 11th-12th intercostal nerve was reattached to a donor nerve in the chest area. The anterior cutaneous branch of the second or third intercostal nerve was used as the donor nerve. Direct, end-to-end nerve coaptation was performed.

Restoring the sensation of the breast becomes increasingly recognized as a critical part of autologous breast reconstruction. A prospective study was conducted of all patients who underwent either innervated or non-innervated deep inferior epigastric perforator (DIEP) flap breast reconstruction in Maastricht University Medical Center between August 2016 and August 2018 and who returned between for a follow-up visit between the start of the study and August 2019. Semmes-Weinstein monofilaments were used for sensory testing of the breast.

Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction

Nerve Coaptation Improves the Sensory Recovery of the Breast in DIEP Flap Breast Reconstruction

The sensory recovery of the donor site to touch was tested at different follow-up moments after the initial surgery. Semmes-Weinstein monofilaments were used for sensory testing. Four areas of the donor site were tested, two areas above and two areas below the scar. Mean monofilament values were calculated for the total donor site and compared between groups.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quantification of Breast Sensation Following Postmastectomy Breast Reconstruction	NCT00588419	Breast Cancer Cancer	breast exam and...	21 Years -	Memorial Sloan Kettering Cancer Center
Nerve Coaptation in LTP Flap Breast Reconstruction	NCT03959943	Breast Cancer	Sensory nerve c...	18 Years - 80 Years	Maastricht University Medical Center
Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction	NCT04093999	Breast Cancer	Sensory nerve c...	18 Years -	Maastricht University Medical Center
Nerve Coaptation in LTP Flap Breast Reconstruction	NCT03959943	Breast Cancer	Sensory nerve c...	18 Years - 80 Years	Maastricht University Medical Center
Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction	NCT04093999	Breast Cancer	Sensory nerve c...	18 Years -	Maastricht University Medical Center

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