Charbonneau Hélène, Pasquié Marie, Peyronnet Benoit, Descazeaud Aurélien, Barry-Delongchamps Nicolas, Della Negra Emmanuel, Mathieu Romain, Karsenty Gilles, Long Jean-Alexandre, Ballereau Charles, Azzouzi Abdel-Rahmène, Pradère Benjamin, Bruyère Franck, Fournier Georges, Lebdai Souhil, Calves Jehanne, Corbel Luc, Vincendeau Sébastien, Fiard Gaelle, Thuillier Caroline, Descotes Jean-Luc, Colin Pierre, Culty Thibaut, Hesbois Audrey, Fuzier Valerie, Savy Nicolas, Pathak Atul, Albaladejo Pierre, Samama Charles Marc, Guerrero Felipe, Misraï Vincent
Department of Anesthesia, Clinique Pasteur, Toulouse, France.
Department of Urology, Clinique Pasteur, 45 avenue de Lombez, BP 27 617, 31076, Toulouse Cedex 3, France.
Trials. 2018 Dec 27;19(1):705. doi: 10.1186/s13063-018-3066-9.
Lower urinary tract symptoms related to benign prostatic obstruction (BPO) are frequent in men aged > 50 years. Based on the use of innovative medical devices, a number of transurethral ablative techniques have recently been developed for the surgical treatment of BPO. In recent years, GreenLight photoselective vaporization of the prostate (PVP) has been considered as a non-inferior alternative to transurethral resection of the prostate. The GreenLight PVP is usually considered as an interesting surgical option for patients treated via oral anticoagulants (OACs) with regard to its haemostatic properties. The aim of this study was to assess the impact of maintaining OAC treatment in patients undergoing PVP.
This study is a multicentre, open-label, randomized controlled trial (RCT) designed to show the non-inferiority of PVP surgery in patients with BPO treated with OACs. This study is designed to enrol 386 OAC-treated patients (treated with vitamin K antagonists and direct oral anticoagulants) who are undergoing PVP for BPO. Patients will be randomized (1:1) to either maintain or stop OAC treatment during the perioperative course. The intervention group will maintain OAC treatment until the day before surgery and resume OAC treatment the day after surgery, whereas the control group will stop OAC treatment (with or without low-molecular-weight heparin bridging therapy) according to the anaesthesia guidelines. The primary outcome of interest to be assessed is the 30-day complications rate according to the Clavien-Dindo classification. The secondary endpoint will examine the 30-day rate of haemorrhagic and thrombotic events. This study will provide 80% power to show non-inferiority, defined as not worse than a 10% (non-inferiority margin) inferior change in the proportion of patients with good outcomes (Clavien-Dindo score < 2), using two-tailed 95% confidence intervals.
This first multicentre RCT in the field is underway to evaluate the safety and efficacy of PVP in patients with ongoing OAC therapy. The study results could influence the perioperative management of OACs in BPO surgery with a high level of evidence.
ClinicalTrials.gov, NCT03297281 . Registered on 29 September 2017.
与良性前列腺梗阻（BPO）相关的下尿路症状在50岁以上男性中很常见。基于创新医疗设备的应用，最近已开发出多种经尿道消融技术用于BPO的手术治疗。近年来，绿激光前列腺选择性汽化术（PVP）被认为是前列腺经尿道切除术的非劣效替代方法。鉴于其止血特性，绿激光PVP通常被视为接受口服抗凝剂（OAC）治疗患者的一种有吸引力的手术选择。本研究的目的是评估在接受PVP的患者中维持OAC治疗的影响。
本研究是一项多中心、开放标签、随机对照试验（RCT），旨在证明PVP手术在接受OAC治疗的BPO患者中的非劣效性。本研究旨在招募386例因BPO接受PVP治疗的OAC治疗患者（接受维生素K拮抗剂和直接口服抗凝剂治疗）。患者将被随机（1:1）分为在围手术期维持或停止OAC治疗两组。干预组将维持OAC治疗直至手术前一天，并在手术后一天恢复OAC治疗，而对照组将根据麻醉指南停止OAC治疗（有或无低分子量肝素桥接治疗）。要评估的主要关注结局是根据Clavien-Dindo分类的30天并发症发生率。次要终点将检查30天出血和血栓形成事件发生率。本研究将提供80%的检验效能以显示非劣效性，定义为使用双侧9
