Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Sensory nerve coaptation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients 18 years or older Unilateral or bilateral DIEP flap breast reconstruction Returned for follow-up between August 2016 and August 2019 Informed consent Exclusion Criteria: Total flap loss complication Flaps that required a take-back Follow-up less than six months postoperatively Only one postoperative measurement at less than 12 months follow-up Mixed reconstructions: an innervated breast reconstruction on one side and a noninnervated breast reconstruction on the other side

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Innervated DIEP flaps<br>Patients in this group underwent immediate or delayed, unilateral or bilateral DIEP flap breast reconstruction with additional sensory nerve coaptation. | Procedure: Sensory nerve coaptation<br>* 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.<br>* Other names: Neurorrhaphy;|
| Noninnervated DIEP flaps<br>Patients in this group underwent immediate or delayed, unilateral or bilateral DIEP flap breast reconstruction without sensory nerve coaptation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean monofilament value as a measure for the sensory recovery of the reconstructed breast | 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. | Through study completion up to 36 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean monofilament value as a measure for the sensory recovery of the reconstructed breast | 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. | Through study completion up to 36 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast reconstruction, DIEP flap, Sensory recovery, Breast sensation, Nerve coaptation