Nerve Coaptation in LTP Flap Breast Reconstruction
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|ClinicalTrials.gov Identifier: NCT03959943|
Recruitment Status : Completed
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment|
|Breast Cancer||Procedure: Sensory nerve coaptation|
|Study Type :||Observational|
|Actual Enrollment :||46 participants|
|Official Title:||Sensory Recovery of the Breast Following Innervated and Non-innervated Lateral Thigh Perforator (LTP) Flap Breast Reconstructions|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||April 2019|
|Actual Study Completion Date :||April 2019|
Innervated LTP flaps
Patients in this group underwent immediate or delayed, unilateral or bilateral lateral thigh perforator (LTP) flap breast reconstruction with additional sensory nerve coaptation.
Procedure: 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.
Non-innervated LTP flaps
Patients in this group underwent immediate or delayed, unilateral or bilateral lateral thigh perforator (LTP) flap breast reconstruction without sensory nerve coaptation.
- The sensory recovery of the reconstructed breast as assessed by Semmes-Weinstein monofilaments [ Time Frame: Through study completion up to 27 months postoperatively ]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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959943
|Maastricht University Medical Center|
|Maastricht, Limburg, Netherlands, 6229 HX|
|Principal Investigator:||René van der Hulst, MD, PhD||Maastricht University Medical Center|