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NCT Number: NCT02166411

Laparoscopic Myomectomy Using Barbed or Conventional Sutures

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 .

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Key information

Conditions

Fibroid Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university

Cairo, Egypt

About this study

  • 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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

myomectomy using barbed sutures

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

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)

Primary outcomes

  1. Operative time

    Time frame: During myomectomy operation

Secondary outcomes

  1. Suturing time of myoma bed

    Time frame: During myomectomy operation

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Jun 18, 2014
Registry last updated
Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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