Laparoscopic Myomectomy Using Barbed or Conventional Sutures

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

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 .

Study Overview

• Status: Completed
• Conditions: Fibroid
• Intervention / Treatment: Procedure: myomectomy using barbed sutures; Procedure: 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 .

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: myomectomy using barbed sutures; .Myoma bed is sutured with barbed sutures	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 ).
ACTIVE_COMPARATOR: myomectomy using conventional sutures; Myoma bed is sutured with conventional sutures	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Operative time	During myomectomy operation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Mohamed Zayed, M.D,PhD, Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department; Study Director: Usama M Fouda, M.D,PhD, Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department; Principal Investigator: Khaled A Elsetohy, M.D,PhD, Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ACTUAL): January 1, 2020

Study Registration Dates

• First Submitted: June 16, 2014
• First Submitted That Met QC Criteria: June 17, 2014
• First Posted (ESTIMATE): June 18, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Myomectomy ,Laparoscopy , Barbed sutures
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Leiomyoma
• Other Study ID Numbers: lap.myomectomy