Temporary Simultaneous Two-arterial Occlusions to Reduce Operative Blood Loss During Laparoscopic Myomectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- operative blood loss
研究概览
简要总结
The aim of this study was to evaluate the efficacy and safety of the temporary simultaneous two-arterial occlusions (TESTO) on operative blood loss during laparoscopic myomectomy.
详细描述
Significant hemorrhage is major perioperative concern in myomectomy, and can result in need of blood transfusion, conversion to hysterectomy, development of hypovolemic shock and postoperative anemia, and delayed recovery. Therefore, methods to decrease operative blood loss during myomectomy in women wishing to preserve their uterus and fertility are important and must be developed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with symptomatic myomas such as menorrhagia, pelvic pressure/pain, or infertility
- •women who were planning to undergo laparoscopic myomectomy
- •women who had ≤ 10 myomas, with the largest myoma ≤ 10 cm
- •women with regular menstrual bleeding
- •women who were not pregnant at the surgery
- •women between 19 and 48 years of age.
排除标准
- •women who underwent concomitant complex surgical procedures at the time of laparoscopic myomectomy, such as severe adhesiolysis or resection for severe endometriosis
- •women who were in postmenopausal or climacteric status
- •women with a history of oophorectomy or salpingo-oophorectomy
- •women with any suggestion of malignant uterine or adnexal diseases
- •women with major medical comorbidities or psychiatric illnesses, which could affect follow-up and/or compliance
- •women who refused to participate or give consent to the procedures
研究组 & 干预措施
LM with TESTO
In subjects allocated to the experimental group, the temporary simultaneous two-arterial occlusions (TESTO) procedure was performed to minimize operative blood loss during laparoscopic myomectomy.
干预措施: LM with TESTO (Procedure)
LM without TESTO
In the control group, no intervention for the temporary simultaneous two-arterial occlusions (TESTO) procedure was made during laparoscopic myomectomy.
干预措施: LM without TESTO (Procedure)
结局指标
主要结局
operative blood loss
时间窗: the day of surgery
Operative blood loss was calculated by the anesthesiology unit as the difference between the total amount of suction and irrigation plus the difference between the total gauze weight before and after surgery.
次要结局
- change in hemoglobin(post-operative day 1)
研究者
Taejong Song
Professor
Kangbuk Samsung Hospital