Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy

Cairo University (CU)

Status and phase: Unknown; Phase 2

Conditions: Hysterectomy

Treatments: Device: Vaginal cuff closure using conventional sutures; Device: Vaginal cuff closure using barbed sutures

Study type: Interventional

Funder types: Other

Identifiers

NCT02998658

Barbed/vaginal cuff

Details and patient eligibility

About

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.

Full 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

Enrollment: 54 estimated patients

Sex: Female

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

54 participants in 2 patient groups

Vaginal cuff closure using barbed sutures

Experimental group

Description:

Vaginal cuff is closed with barbed sutures

Treatment:

Device: Vaginal cuff closure using barbed sutures

Vaginal cuff closure using conventional sutures

Active Comparator group

Description:

Vaginal cuff is closed with conventional sutures

Treatment:

Device: Vaginal cuff closure using conventional sutures