Laparoscopic Myomectomy Using Barbed or Conventional Sutures

Fibroid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166411
• Other study ID #: lap.myomectomy
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: January 2020

Study information

• Verified date: October 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: January 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibroid
• Leiomyoma

Intervention

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 ).
• 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)

Locations

Country	Name	City	State
Egypt	Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Greenberg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):621-3. doi: 10.1016/j.jmig.2008.06.004. Epub 2008 Jul 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time		During myomectomy operation
Secondary	Suturing time of myoma bed		During myomectomy operation