Clinical trial NCT02998658: Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy
Official title: Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hysterectomy
Keywords: Laparoscopy
Barbed sutures
Hysterectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 54
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Patients with an indication for hysterectomy ( i.e. pain, bleeding and pressure symptoms)

Exclusion Criteria:

* Genital malignancy
* Uterine size more than 16 weeks
* Coagulation defects or concurrent anticoagulant therapy
* Pregnancy
* Compromised cardiopulmonary status
* Contraindications for general anesthesia

Primary outcomes:
measure: Suturing time of vaginal cuff
timeFrame: During hysterectomy operation
Secondary outcomes:
measure: Operative time
timeFrame: During hysterectomy operation
Other outcomes:
Locations:
city: Caene
country: Egypt
facility: Cairo university
Study officials:
affiliation: Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
name: Usama M Fouda, Prof.
role: STUDY_DIRECTOR
affiliation: Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
name: Khaled A Elsetohy,, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Einarsson JI, Cohen SL, Gobern JM, Sandberg EM, Hill-Lydecker CI, Wang K, Brown DN. Barbed versus standard suture: a randomized trial for laparoscopic vaginal cuff closure. J Minim Invasive Gynecol. 2013 Jul-Aug;20(4):492-8. doi: 10.1016/j.jmig.2013.02.015. Epub 2013 May 14.