NCT02166411

Laparoscopic Myomectomy Using Barbed or Conventional Sutures

Laparoscopic Myomectomy Using Barbed or Conventional Sutures . A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare operative data and early postoperative outcomes of laparoscopic myomectomy using barbed sutures with those of laparoscopic myomectomy using conventional sutures .

Detailed description

• Till now , there is only one small randomized controllrd study (n=22 in each arm) which compared the use of barbed suture with conventional suture in laparoscopic myomectomy .The myoma bed was closed with either conventional polyglactin suture or unidirectional barbed suture . The operative time was shorter in the barbed suture group (73.3 ± 21.4 min Vs. 80.7 ± 18.6 min) but this difference failed to reach statistical significance because of small sample size . However, the time required to suture the myoma beds was significantly lower in the barbed suture group .

Conditions

• Fibroid

Interventions

Type	Name	Description
PROCEDURE	myomectomy using barbed sutures	A transverse incision will be made over the myoma using unipolar hook and a cleavage plane between the myoma and uterus will be developed by sharp dissection. After the identification of the cleavage plane, the fibroid will be enucleated by means of adequate traction with a strong grasper and countertraction maneuvers with another grasping forceps . Bipolar forceps will be used to coagulate bleeding points . The myometrial edges will be reapproximated in one or two layers (according to the depth of the uterine wound) by using a 24-cm × 24-cm 0 polydioxanone double-armed suture on a 26-mm half-circle reverse cutting needle( STRATAFIX™ Spiral PDO Knotless Tissue Control Device, Ethicon Inc , Somerville, NJ, USA ).
PROCEDURE	myomectomy using conventional sutures	A transverse incision will be made over the myoma using unipolar hook and a cleavage plane between the myoma and uterus will be developed by sharp dissection. After the identification of the cleavage plane, the fibroid will be enucleated by means of adequate traction with a strong grasper and countertraction maneuvers with another grasping forceps . Bipolar forceps will be used to coagulate bleeding points . Myometrial edges will be re-approximated using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ)

Timeline

• Start date: 2014-01-01
• Primary completion: 2019-01-01
• Completion: 2020-01-01
• First posted: 2014-06-18
• Last updated: 2020-03-13

Locations

1 site across 1 country: Egypt