Laparoscopic Myomectomy Using Barbed or Conventional Sutures

NCT ID: NCT02166411

Last Updated: 2020-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2020-01-31

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 .

Conditions

Fibroid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

myomectomy using barbed sutures

.Myoma bed is sutured with barbed sutures

Group Type: EXPERIMENTAL

myomectomy using barbed sutures

Intervention Type: PROCEDURE

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

Myoma bed is sutured with conventional sutures

Group Type: ACTIVE_COMPARATOR

myomectomy using conventional sutures

Intervention Type: PROCEDURE

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)

Interventions

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 ).

Intervention Type: 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)

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Usama M Fouda

M.D, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Zayed, M.D,PhD

Role: STUDY_CHAIR

Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department

Usama M Fouda, M.D,PhD

Role: STUDY_DIRECTOR

Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department

Khaled A Elsetohy, M.D,PhD

Role: PRINCIPAL_INVESTIGATOR

Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department

Locations

Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 18619922 (View on PubMed)

Other Identifiers

lap.myomectomy

Identifier Type: -

Identifier Source: org_study_id