Department of Plastic, Reconstructive and Hand Surgery, Maastricht University Medical Center, Maastricht, the Netherlands; GROW - Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands.
Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, the Netherlands.
Breast. 2024 Apr;74:103691. doi: 10.1016/j.breast.2024.103691. Epub 2024 Feb 9.
Sensory nerve coaptation has great potential to restore sensation after autologous breast reconstruction. However, blinded and randomized studies are lacking. We therefore present the preliminary results of our ongoing double-blinded randomized controlled trial that compares sensory recovery of innervated versus non-innervated DIEP flaps.
Patients who underwent DIEP flap breast reconstruction between July 2019 and February 2022 were included and randomized. The anterior cutaneous branch of the second or third intercostal nerve was coapted. Pre- and postoperative sensory testing was performed with Semmes-Weinstein Monofilaments, Pressure Specified Sensory Device, and a thermostimulator, for tactile and temperature thresholds.
This interim analysis comprised 41 patients contributing 29 innervated and 38 non-innervated breasts. At 24 months of follow-up, the mean monofilament value of the flap skin was lower in innervated than in non-innervated flaps (4.48 vs. 5.20, p = 0.003). Touch thresholds were lower the center of the innervated flaps (47.8 vs. 71.2 g/mm, p = 0.036), and heat pain was more often imperceptible in non-innervated flaps (42.1% vs. 10.3%, p = 0.004). No adverse events were associated with sensory nerve coaptation.
These preliminary results indicate superior sensibility and recovery of protective sensation in innervated compared with non-innervated DIEP flaps. Although the results of the completed trial must be awaited to establish the full clinical impact, including highly anticipated quality of life outcomes, we encourage continuation of scientific and clinical efforts in this promising technique.
感觉神经吻合在自体乳房重建后恢复感觉方面具有巨大潜力。然而，缺乏盲法和随机研究。因此，我们展示了正在进行的双盲随机对照试验的初步结果，该试验比较了神经化与非神经化 DIEP 皮瓣的感觉恢复。
纳入 2019 年 7 月至 2022 年 2 月期间接受 DIEP 皮瓣乳房重建的患者，并进行随机分组。第二或第三肋间神经前皮支吻合。使用 Semmes-Weinstein 单丝、压力特定感觉装置和热刺激器进行术前和术后感觉测试，以测量触觉和温度阈值。
本中期分析包括 41 例患者，其中 29 例皮瓣有神经支配，38 例无神经支配。在 24 个月的随访中，神经化皮瓣的单丝值低于非神经化皮瓣（4.48 对 5.20，p=0.003）。感觉阈值在神经化皮瓣的中心较低（47.8 对 71.2 g/mm，p=0.036），并且非神经化皮瓣中热痛更常无法感知（42.1%对 10.3%，p=0.004）。感觉神经吻合无不良事件发生。
这些初步结果表明，与非神经化 DIEP 皮瓣相比，神经化皮瓣具有更好的敏感性和保护性感觉恢复。尽管必须等待完成试验的结果来确定其对临床的全面影响，包括预期的生活质量结果，但我们鼓励继续在这项有前途的技术方面进行科学和临床努力。
