Retroperitoneal Ligation of Uterine Artery in Total Laparoscopic Hysterectomy for Enlarged Uterus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Operative blood loss
研究概览
简要总结
This randomized trial is aimed to investigate the role of retroperitoneal TLH in enlarge uterus.
详细描述
Laparoscopic hysterectomy is one of the most common gynecologic surgeries worldwide. Generally, in total laparoscopic hysterectomy (TLH), uterine arteries are coagulated or transected close to the uterus, alongside the cervix, like surgical technique of a conventional total abdominal hysterectomy. Recently, several studies showed that ligation of uterine artery where it originates from the internal iliac artery during TLH (so-called "retroperitoneal TLH") is effective for reducing blood loss. However, the application of this technique to clinical practice have not been well investigated in terms of its efficacy and safety. Moreover, most of the previous studies on retroperitoneal TLH were small case series or retrospective comparative studies with conventional TLH. Therefore, the investigators conducted this randomized trial to investigate the role of retroperitoneal TLH in enlarge uterus.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •absence of pregnancy at the time of presentation
- •uterine volume between 12 and 18 weeks of gestation by pelvic examination
- •appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)
排除标准
- •any suggestion of malignant uterine or adnexal diseases
- •any major medical comorbidities or psychiatric illnesses, which could affect follow-up and/or compliance
- •an inability to understand and provide written informed consent.
研究组 & 干预措施
Retroperitoneal hysterectomy
In subjects allocated to the experimental group, which the uterine vessels were ligated where it originates from the internal iliac artery,
干预措施: Retroperitoneal liagation of uterine artery (Procedure)
Classical hysterectomy
The operative technique of classical total laparoscopic hysterectomy (TLH) performed in the control group was comparable to that of retroperitoneal TLH, except for one that coagulation and transection of uterine artery was achieved using an energy device alongside the cervix
干预措施: Classical ligation of uterine artery (Procedure)
结局指标
主要结局
Operative blood loss
时间窗: Operation day
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
未报告次要终点
研究者
Taejong Song
Professor
Kangbuk Samsung Hospital