Hysterectomy Clinical Trial
Official title:
Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy. A Randomized Controlled Trial
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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