Corson S L, Brill A I, Brooks P G, Cooper J M, Indman P D, Liu J H, Soderstrom R M, Vancaillie T G
815 Locust Street, Philadelphia, PA 19017, USA.
J Am Assoc Gynecol Laparosc. 2000 Nov;7(4):489-97. doi: 10.1016/s1074-3804(05)60361-1.
To compare a distensible multielectrode balloon for endometrial ablation with electrosurgical ablation performed by a combined resection-coagulation technique.
Randomized, prospective trial (Canadian Task Force classification I). Setting. Eight centers.
Women with menorrhagia validated with a standardized pictorial blood loss assessment chart (PBAC), without intracavitary organic uterine disease, who failed or poorly tolerated medical therapy. Intervention. Results in 122 patients treated by Vesta and 112 treated surgically, evaluable at 1 year, were compared, with success defined as monthly blood loss of less than 80 ml and avoidance of additional therapy.
Pretreatment PBAC scores for patients treated by Vesta and resection or rollerball were 535+/-612 and 445 +/- 313, respectively; at 1 year they were 18+/-37 and 28+/-60, respectively. With PBAC below 75 as the definition of success, 86.9% of Vesta-treated patients were successful compared with 83.0% treated by rollerball or resection. Total amenorrhea, defined as no visible bleeding and no use of protective products, was 31.1% and 34. 8%, respectively. None of the outcome comparisons between treatments showed statistical difference. Complications in both groups were few and minor. Most (86.6%) Vesta procedures were carried out with paracervical block with or without intravenous sedation in an office or outpatient setting, compared with 79.7% epidural or general anesthesia for rollerball or resection.
The Vesta system of endometrial ablation is equally effective and safe as classic resectoscopic methods. Potential advantages include avoidance of fluid and electrolyte disturbance associated with intravasation of distending media, and ability to perform the procedure under local anesthesia in an office setting with less total operating time.
比较用于子宫内膜消融的可扩张多电极球囊与采用联合切除-凝固技术进行的电外科消融。
随机前瞻性试验(加拿大工作组分类I)。地点。八个中心。
经标准化图像失血评估图(PBAC)验证为月经过多、无宫腔内器质性子宫疾病且药物治疗失败或耐受性差的女性。干预措施。比较了122例接受Vesta治疗的患者和112例接受手术治疗的患者在1年时的结果,成功定义为每月失血量少于80毫升且无需额外治疗。
接受Vesta治疗以及接受切除或滚球治疗的患者治疗前PBAC评分分别为535±612和445±313;1年时分别为18±37和28±60。以PBAC低于75作为成功的定义,接受Vesta治疗的患者中有86.9%成功,而接受滚球或切除治疗的患者中这一比例为83.0%。完全闭经定义为无可见出血且无需使用防护用品,分别为31.1%和34.8%。治疗组之间的任何结果比较均无统计学差异。两组并发症均较少且轻微。大多数(86.6%)Vesta手术在办公室或门诊环境中采用宫颈旁阻滞联合或不联合静脉镇静进行,而滚球或切除手术则有79.7%采用硬膜外或全身麻醉。
Vesta子宫内膜消融系统与传统的宫腔镜切除方法同样有效且安全。潜在优势包括避免与扩张介质血管内渗相关的液体和电解质紊乱,以及能够在办公室环境中局部麻醉下进行手术且总手术时间更短。