Fibroid
Conditions
Keywords
Myomectomy ,Laparoscopy , Barbed sutures
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 .
Interventions
PROCEDUREmyomectomy 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 ).
PROCEDUREmyomectomy 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)
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Operative time | During myomectomy operation |
Secondary
| Measure | Time frame |
|---|---|
| Suturing time of myoma bed | During myomectomy operation |
Countries
Egypt
Outcome results
None listed