Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy. A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Suturing time of vaginal cuff
研究概览
简要总结
The aim of this study is to estimate whether the use of the barbed suture facilitates laparoscopic suturing of the vaginal cuff during total laparoscopic hysterectomy.
详细描述
Vaginal cuff suturing is a significant step during hysterectomy with regard to operating time and a critical passage for the risk of vaginal cuff dehiscence. Vaginal cuff dehiscence is a severe adverse event and occurs more frequently after total laparoscopic hysterectomy (0.3-3.1 %) compared to abdominal and vaginal hysterectomy
Barbed suture is a new type of sutures introduced to facilitate laparoscopic suturing.When compared with conventional smooth suture, barbed suture has external barbs that anchor the suture to the tissues and prevent the retrograde movement of suture thread during suturing. Consequently, laparoscopic suturing can be performed easily without the need for suture locking, without applying traction on suture thread by the assistant and without tying knots at both ends of the suture line In gynecology, barbed sutures have been used in minimally invasive ,myomectomy hysterectomy, ovarian cystectomy and sacrocolpopexy. There is a growing body of evidence that the use of barbed sutures in these procedures facilitates laparoscopic suturing and significantly reduces suturing time, total operating time and intraoperative blood loss To date only two small randomized controlled trials compared the effectiveness of the bidirectional knotless barbed suture versus standard suture in the repair of vaginal cuff
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
- 30 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with an indication for hysterectomy ( i.e. pain, bleeding and pressure symptoms)
排除标准
- •Genital malignancy
- •Uterine size more than 16 weeks
- •Coagulation defects or concurrent anticoagulant therapy
- •Pregnancy
- •Compromised cardiopulmonary status
- •Contraindications for general anesthesia
研究组 & 干预措施
Vaginal cuff closure using barbed sutures
Vaginal cuff is closed with barbed sutures
干预措施: Vaginal cuff closure using barbed sutures (Device)
Vaginal cuff closure using conventional sutures
Vaginal cuff is closed with conventional sutures
干预措施: Vaginal cuff closure using conventional sutures (Device)
结局指标
主要结局
Suturing time of vaginal cuff
时间窗: During hysterectomy operation
次要结局
- Operative time(During hysterectomy operation)
