Department of Urology, Seoul National University Hospital, Seoul, Korea.
Department of Urology, Pusan National University Yangsan Hospital, Yangsan, Korea.
Investig Clin Urol. 2022 Jul;63(4):475-481. doi: 10.4111/icu.20220092.
Thermal damage and inflammatory responses of the sphincter and neurovascular bundles (NVBs) are responsible for post-prostatectomy incontinence and erectile dysfunction. Intraoperative hypothermia in the pelvic cavity may reduce the occurrence of these complications. We evaluated the feasibility of a novel rectal cooling system using an animal model. A novel rectal cooling system consisting of a cooling console and a multi-lumen rectal balloon was developed. We conducted animal tests on male pigs to evaluate the efficacy and safety of the system. The primary endpoint was to maintain the temperature of the NVBs at 25℃ (±5℃) during and after the electrocauterization of the bladder neck for 10 seconds. The safety endpoint was device-related complications or significant changes in the core body temperature of the pigs. The NVB temperature was below 30℃ within 3 minutes of activation of the rectal balloon. The temperature of the proximal NVB was consistently maintained below 25℃ in all cases. The temperature 1 cm from the bladder neck did not rise above 38℃ and dropped to the initial level within 1 minute after electrocauterization. During cooling, the minimum temperature at the apex of the prostate was reduced to 10.1℃. There were no device-related complications or significant changes in core body temperature throughout the experiment. Animal tests suggest the feasibility and safety of this novel rectal cooling system. A first-in-human trial to assess the safety and efficacy of this system during radical prostatectomy is warranted.
肛门括约肌和神经血管束（NVBs）的热损伤和炎症反应是导致前列腺切除术后尿失禁和勃起功能障碍的原因。术中盆腔低温可能会降低这些并发症的发生几率。我们使用动物模型评估了一种新型直肠冷却系统的可行性。开发了一种由冷却控制台和多腔直肠气囊组成的新型直肠冷却系统。我们对雄性猪进行了动物试验，以评估该系统的疗效和安全性。主要终点是在电灼膀胱颈部 10 秒期间和之后将 NVB 温度维持在 25℃（±5℃）。安全性终点是与器械相关的并发症或猪的核心体温出现显著变化。直肠气囊激活后 3 分钟内，NVB 温度低于 30℃。在所有情况下，近端 NVB 的温度均保持在 25℃以下。距膀胱颈部 1cm 处的温度未升高至 38℃以上，电灼后 1 分钟内降至初始水平。在冷却过程中，前列腺顶点的最低温度降至 10.1℃。整个实验过程中均未发生与器械相关的并发症或核心体温出现显著变化。动物试验表明，这种新型直肠冷却系统具有可行性和安全性。有必要进行首例人体试验，以评估该系统在根治性前列腺切除术中的安全性和疗效。
