Laparoscopic Myomectomy Using Barbed or Conventional Sutures

Study Overview
=================
Brief 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 .

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

Conditions
-----------------
Fibroid

Intervention / Treatment
-----------------
* Procedure: myomectomy using barbed sutures
* Procedure: myomectomy using conventional sutures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the presence of one to three symptomatic intramural or subserosal myomas (with largest fibroid diameter less than 10 cm). Exclusion Criteria: submucosal myoma calcified myomas uterine size more than 16 weeks suspension of genital malignancy coagulation defects or concurrent anticoagulant therapy pregnancy compromised cardiopulmonary status previous treatment with gonadotropin-releasing hormone analogue contraindications for general anesthesia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: myomectomy using barbed sutures<br>.Myoma bed is sutured with barbed sutures | Procedure: myomectomy using barbed sutures<br>* 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 ).<br>|
| Active Comparator: myomectomy using conventional sutures<br>Myoma bed is sutured with conventional sutures | Procedure: myomectomy using conventional sutures<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  | During myomectomy operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suturing time of myoma bed |  | During myomectomy operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myomectomy ,Laparoscopy , Barbed sutures