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临床试验/NCT02998658
NCT02998658Unknown2 期

Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy. A Randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2017年2月1日最近更新:
适应症
干预措施

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

Experimental

Vaginal cuff is closed with barbed sutures

干预措施: Vaginal cuff closure using barbed sutures (Device)

Vaginal cuff closure using conventional sutures

Active Comparator

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Usama M Fouda

Prof.

Cairo University

研究点 (1)

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