Single-port Laparoscopic Myomectomy Using Barbed Suture Versus Multi-port One: a Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Suturing time
研究概览
简要总结
The aim of this study is to test our hypothesis that the use of unidirectional knotless barbed suture in single-port laparoscopic myomectomy could facilitate the suture of uterine wall defect after myoma enucleation as multi-port laparoscopic myomectomy did.
详细描述
The investigators plan to perform a multi-center randomized clinical trial on women scheduled for laparoscopic myomectomy. All women will get the same preoperative and postoperative care. Women will be assigned by chance to one of two groups: one group will receive single-port laparoscopic myomectomy using V-Loc™ suture material (study group). The other group will receive conventional multi-port laparoscopic myomectomy using V-Loc™ suture material (control group). The investigators will collect information on suturing time and complications related to surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 55 years
- •Image-confirmed uterine myoma
- •Number of myoma ≤2 and largest size ≤10cm
- •Women who were scheduled to have laparoscopic myomectomy
- •Appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)
排除标准
- •Women with pedunculated subserosal myoma or submucosal myoma
- •Women undergoing concomitant complex surgical procedures at the time of laparoscopic myomectomy such as severe adhesiolysis or resection for severe endometriosis
- •Women with any suggestion of malignant uterine or adnexal diseases
- •Women with diabetics, malignancy, or malnutrition, which can affect wound healing
- •Women having major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance
- •Women who refuse to participate or give consent to the procedures
结局指标
主要结局
Suturing time
时间窗: Intra-operative
the time duration for the suture of uterine wall defect after myoma enucleation during laparoscopic myomectomy
次要结局
- Cosmetic satisfaction(Post-surgery 1 month and 3 month)