A Randomized Controlled Trial of Hand-assisted Laparoscopic Myomectomy Versus Abdominal Myomectomy: Surgical Outcomes and Patient Satisfactions
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Patient satisfaction about surgery
研究概览
简要总结
The aim of this study was to evaluate the feasibility and usefulness of Hand-assisted laparoscopic surgery (HALS) for myomectomy, and compare it with the open approach in myomectomy.
详细描述
Uterine myomas are the most common benign tumor of the female genital tract and the leading indication for hysterectomy. Despite the fact that laparoscopic myomectomy is becoming increasingly popular, laparoscopic myomectomy remains underutilized because of inherit limitations. The limitations include technical challenges such as dissection of the myoma from its bed using the correct plane or multilayer closure of the myoma bed and the concern about the strength of the suturing and the subsequent risk of uterine rupture. As a result, laparoscopic myomectomy is currently performed only by expert surgeons.
Hand-assisted laparoscopic surgery (HALS) is a unique surgical approach that may overcome the limitations of pure laparoscopic surgery. HALS is not only less invasive than open surgery but also causes less technical challenges than laparoscopic surgery based on its manual nature and ability to use retractors. In gynecologic field, HALS has also been employed in ovarian cancers and large ovarian tumors.
In theory, HALS seems appropriate procedure, similar to the open approach, for patients with multiple or huge myomas. To date, no report has evaluated the feasibility and usefulness of HALS compared with open surgery (OS).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria were as follows: women who had myoma-related symptoms such as menorrhagia, pelvic pressure/pain, or infertility; women who were not pregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks); and women who were appropriated medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2).
排除标准
- •Exclusion criteria included any other uterine or adnexal abnormalities (e.g., abnormal endometrial thickness, and suspected ovarian or uterine malignancy), any sign of genital infection, presence of submucosal or pedunculated myoma as a dominant myoma, treatment of gonadotropin-releasing hormone (GnRH) agonist 2 months before surgery, or an inability to understand and provide written informed consent.
结局指标
主要结局
Patient satisfaction about surgery
时间窗: 1 month after surgery
次要结局
未报告次要终点