Cancer - Prostate(구연) (E-110) 로봇 보조 복강경 근치적 전립선적출술 중 직장 냉각 장치(BelloCool™)를 이용한 골반 저체온증 치료의 적합성 및 안전성: 제 I/II 상 임상시험 서울대학교 의과대학 비뇨의학과 박대형, 유상현, 윤현식, 정규환, 이경채, 도밍턴, 김환익, 서준교, 육형동, 구자현, 곽 철, 김현회, 정창욱 PURPOSE: We evaluated the safety of pelvic hypothermia using a licensed rectal cooling balloon device (BelloCool™) during robot-assisted Laparoscopic radical prostatectomy (RALP), as a potential therapy to minimize urinary or sexual dysfunction after surgery. METHODS: We conducted a prospective phase I/II trial. We enrolled 20 patients who underwent RALP from October 2019 to April 2020. The inclusion criteria were patients with prostate cancer who planned RALP, who had an International Index of Erectile Function-5 score of 12 or higher. Regional pelvic cooling was achieved using a rectal cooling balloon. The primary outcome was the rate of device-related complication. The temperature of the rectal balloon, the proximal and distal temperatures of the neurovascular nerve bundle were measured during surgery to evaluate the feasibility of the device. The immediate postoperative inflammatory response and postoperative complications were analyzed. RESULTS: Pelvic hypothermia was achieved in all patients. The median temperature of the rectal balloon was 4.2 °C. The lowest median temperature of the neurovascular nerve bundle was 24.9 °C (IQR 22.4-26.9). There were five cases of Clavien-Dindo grade I complication (acute urinary retention, Foley catheter obstruction, unstable angina and leg numbness), two cases of grade II complication (wound bleeding and hematuria), and one case of grade IIIa complication (ischemic heart disease). However, those were not device-related complications. CONCLUSION: Pelvic hypothermia therapy using a rectal cooling balloon device during RALP was safe and feasible. Confirmatory trial to assess the effect of this device to improve urinary and sexual function after radical prostatectomy is warranted. Figure 1. BelloCool™, a licensed rectal cooling balloon device. keywords : hypothermia, prostatectomy, rectal cooling